Software version CareSuite 5.1 and later.

General Hospital and Personal Use Devices

Unclassified

No

NJ Canada, Australia, Austria,Denmark, Finland, Germany Norway,Portugal, Sweden, France,Netherlands, Spain.

CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager || Software: CareSuite 5.1 and later

Batch #: MM-090406 with CCII-0901

General and Plastic Surgery Devices

Unclassified

No

Nationwide Distribution -- CA, IA, KY, IL, TX, SC & UT.

Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), 250-500 per vial, Batch #: MM-090406 with CCII-0901. || Maggot therapy is intended to debride serious non-healing (chronic) wounds, and the dressing intended to confine the maggots to the wound.

SoftPath GUI versions 4.2.3.4, 4.2.4.1, 4.3.0.3, 4.3.0.4.

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution: Throughout USA and Canada.

SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). || SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). || SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). || SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.

Versions 2.2.0.6.3 and 2.2.0.7.1.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution: including states of GA, LA, and NH.

Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Soft Query Results Reporting version 2.2.0.6.3 was released for General Availability on 09/11/03. || Soft Query Results Reporting version 2.2.0.7.1 was released for General Availability on 01/08/04.

Versions 3.17.5, 3.17.6, 3.17.7, 3.17.8, 4.1.0, and 4.1.1.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide - USA, including the states of CA, CO, CT, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, PA, SD, TX, WI, and WV

SoftPath GUI Releases 3.17 through 4.1.0. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Manufacture/Distribution Dates: || Version 3.17.5 10/14/2003. || Version 3.17.6 03/28/2003. || Version 3.17.7 07/02/2003. || Version 3.17.8 03/03/2004. || Version 4.1.0 07/03/2003. || Version 4.1.1 10/03/2003. || Intended for use in the Pathology Lab for receiving and accessioning specimens, documenting tissue processing, producing material labels, generating final diagnostic reports, and creating billing and management reports for surgical, GYN, NON-GYN, and Autopsy cases.

Version 3.17.7.6

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution to the states of IN, NC, NH, and NJ.

SoftPath GUI Versions 3.17 and 4.1. || SCC Soft Computer 5400 Tech Data Drive, Clearwater, FL 33760. || Manufactured: Version 3.17.7.6 10/23/2003

Version 3.17.6.3.1.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide distribution: One hospital in NY.

SoftPath GUI version 3.17.6.3.1. || SCC Soft Computer 34350 US Highway 19 N, Palm Harbor, FL 34684. || Date of Manufacture: || Version 3.17.6.3.1 06/03/2003.

version 4.0.4.10.1.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution: 1 hospital in Alaska.

SoftWeb version 4.0.4.10.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Manufacture Date: 05/16/2006.

Serial numbers: NXT1001-1079, NLB0901901IE, NBL0902101IE, NBL0902501IE, NBA1000501IE, NBC1001501IE, NBC1002001IE, NBC1002301IE, NBC1002901IE, NBE1001301IE, NCE1001901IE, NBF1000701IE, NBD1000101IE.

General and Plastic Surgery Devices

Unclassified

No

Worldwide Distribution: USA , including the states of AZ, CA, CO, FL, GA, IA, KY, MN, MO, NV, NY, OH, OR, RI, TX, VA, WI, and the countries of Germany, Hungary, Indonesia, Italy, Netherlands, and Switzerland.

Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System || CUSANXT1:Latex Free, Rx only: || Integra LifeSciences (Ireland) Limited, || County Offaly, Ireland; || Distributed by Integra Life Sciences Corporation || 311 Enterprise Drive || Plainsboro, NJ 08536.

Serial numbers: NXT1022, NXT1023, NXT1026, NXT1043, NXT1050, NXT1051, NXT1056, NXT1057, NXT1008, NXT1018, NXT1019, NXT1029, NXT1030, NXT1042, NXT1062, NXT1063, NXT1064, NXT1067, NXT1069, NXT1070, NBC1001901IE.

General and Plastic Surgery Devices

Unclassified

No

Worldwide Distribution: USA , including the states of AZ, CA, CO, FL, GA, IA, KY, MN, MO, NV, NY, OH, OR, RI, TX, VA, WI, and the countries of Germany, Hungary, Indonesia, Italy, Netherlands, and Switzerland.

Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System || CUSANXT2: Latex Free, Rx only. || Integra LifeSciences (Ireland) Limited || County Offaly, Ireland || Distributed by Integra Lifesciences Corporation || 311 Enterprise Drive || Plainsboro, NJ 08536.

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General and Plastic Surgery Devices

Unclassified

No

Wordwide

Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.

Versions 1.1.6.x and 1.1.7.x.

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution--USA (nationwide) and the country of Canada.

SoftReports versions 1.1.6.x and 1.1.7.x || SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports).

Versions 4.0.4.7, 4.5.1.3.

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution: USA, including the states of CA, CT, DE, FL, IA, KY, MA, MA, MI, MN, NJ, NY, OH, PA, TX, VA, and WI, and the country of Canada.

SoftMic Versions 4.0.4.7, 4.5.1.3. || Version 4.0.4.7 Manufactured 02/03/2010. || Version 4.5.1.3 Manufactured 03/18/2010. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.

Versions: SoftID.NET 2.0.0.6 - 4/3/2007,  SoftID.NET 2.0.0.7 - 6/21/2007,  SoftID.NET 2.0.0.8 - 8/29/2007,  SoftID.NET 2.0.0.9 - 10/01/2007,  SoftID.NET 2.0.0.10 - 10/25/2007,  SoftID.NET 2.0.0.11 - 11/07/2007,  SoftID.NET 2.0.0.12 - 2/08/2008,  SoftID.NET 2.0.0.13 - 5/13/2008,  SoftID.NET 2.0.0.14 - 6/12/2008,  SoftID.NET 2.0.0.15 - 8/15/2008,  SoftID.NET 2.0.0.16 - 10/15/2008,  SoftID.NET 2.0.0.17 - 12/15/2008,  SoftID.NET 2.0.0.18 - 2/02/2009,  SoftID.NET 2.0.0.19 - 5/18/2009.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide distribution: AR, CA, FL, IL, IN, KS,LA, MA, MI, MN, MO, NC, ND,NH, NJ, NY, OH, PA, RI, TN, TX, VA and WI.

SoftID.NET versions 2.0.0.6 - 2.0.0.19. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || SoftID.NET is to be used in a medical or clinical laboratory setting by knowledgeable, trained, and experienced professionals. SoftID.NET supports bedside collection of patient specimens used in diagnostic testing. This product is integrated with Soft Computer's SoftLab, SoftScape and can also interface with all other SCC laboratory systems and Hospital Information Systems (HIS).

All units of these iSite PACS.

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution.

iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92; || Product is manufactured and distributed by Philips Medical Systems, Foster City, CA || iSite PACS: iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems.

All units of these iSite PACS.

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution.

iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, || Versions: 3.6.96, 3.6.101, 3.6.110, 4.1.96, 4.1.101, and 4.1.110 || ; Product is manufactured and distributed by Philips Medical Systems, Foster City, CA || ViewForum Applications: iSite ViewForum Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. iSite ViewForum Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. iSite ViewForum Applications performs viewing, image manipulation, communication, printing, and quantification of images.

Lot number: 000543118

General and Plastic Surgery Devices

Unclassified

No

Nationwide -- Including CA, GA, IL, MO, MS, TX, and VA.

HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of catheters or cannulae.film, 10cm x 12.5 cm, Paul Hartmann AG, 89522 Heidenhiem, Germany

versions D.03, E.0, or E.01 of the software

General Hospital and Personal Use Devices

Unclassified

No

Worldwide distribution: USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Kenya, Latvia, Malaysia, Netherlands, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.

Philips IntelliVue Clinical Information Portfolio software as follows: || 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link

Serial Numbers: 1P00100 - 1P00XXX

Gastroenterology-Urology Devices

Unclassified

No

Worldwide Distribution -- USA ( nationwide ) and the countries of Australia, Belgium, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Pakistan, Republic of Korea, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand and Vietnam.

Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. || A blood component separator used for therapeutic plasma exchanges.

Lot/Unit Codes: 245765R, 245763R, 245766R, 245768, 245769, 252549, 245770, 252020, 252021, 252530, 252532, 252533, 256080, 256081, 256082, 256083, 256084, 256085, 260082, 256086, 256087, 256088, 256089, 256090, 256091, 256092, 261879, 261880.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution

PDI Alcohol Prep Pads packaged in the INRatio kit. || PDI Alcohol Prep Pads, 100/box. || Alcohol Prep Pads, packaged in the Alere INRatio¿ 2 PT/INR Home Monitoring Kit; or Hemosense INRatio¿ 2 Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the Hemosense INRatio¿ Prothrombin Time/INR Testing Kit, Self-Test System; || Alcohol Prep Pads, packaged in the INRatio Starter Kit Product || Model Number: 0200086, 0200432, 0100007, 0100072 || The Alere INRatio¿2 PT/INR Home Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio¿2 PT/INR Home Monitoring System is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio¿2 PT/ INR Home Monitoring System is not intended to be used for screening purposes. The Alere INRatio¿2 PT/INR Home Monitoring System should only be used with a prescription from your physician. The INRatio2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio2 PT Monitoring System is not intended to be used for screening purposes. The INRatio2 PT Monitoring system should only be used with a prescription from your physician. The INRatio¿ system performs Prothrombin Time (PT) testing on fresh, capillary whole blood. The PT test is the principle assay used to monitor warfarin therapy. Patients taking warfarin and other oral anticoagulants should consult with their healthcare provider before adjusting their dosage. The thromboplastins used in performing PT tests can vary substantially causing differences in results between methods. The International Normalized Ratio (INR) is a mathematical correction of the PT result that adjusts for differences in thromboplastins. Consult your physician for the appropriate therapeutic range for you.

SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7.

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution.

SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. || SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases.

510K #: K981262 Device Listing #: D001100 Item Number C4601S Lot #: 1112631 Lot #: 1112632 Lot #: 1112633 Lot #: 1112634 Lot #: 1112635 Lot #1113361

General and Plastic Surgery Devices

Unclassified

No

Worldwide Distribution

Integra CUSA EXcel Sterile Tips Rx Only || Single Use Only || Product Usage: For usage in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

All serial numbers.

Gastroenterology-Urology Devices

Unclassified

No

Worldwide distribution including USA, Canada, Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Netherlands, UK, Hong Kong, Hungary, India, Italy, Iran, Ireland, Israel, Jordan, Korea, Kuwait, Lebanon, Libya, Luxembourg, Egypt, Finland, France, Germany, Japan, Malaysia, Mexico, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Romania, Russia, Spain, Saudi Arabia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, Vatican, Vietnam, and Greece.

Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.

UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.

Dental Devices

Unclassified

No

Nationwide Distribution .

Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. || Biotene Mouth Spray is used for the treatment of dry mouth

Lot Numbers: 2012-0809; 2012-0903; 2012-1011.

General and Plastic Surgery Devices

Unclassified

No

US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV.

SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. || Product Usage: || SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.