Smiths Medical ASD Inc.

Part No. (Lot No.): CMZ3241N (DS009716), ST16EN80NSC194N (DS009794),  SU15AN70NSC153N (DS009577), FT17IN60NGC114N (DS009894), CMZ3331N (DS009761), XU17GS50NSF046N (DS009609), FT17IN60NGC114N (DS009861), AA16ES70NSC110N (DS009586), FT17IN70NSC111N (DS009856), FT16IN60NGC053N (DS009540), FU15AN55NSA076N (DS009464), AT17IS60NGC105N (DS009811)

Anesthesiology Devices

2

No

Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.

Bivona¿ Tracheostomy Tube Tracheostomy Tubes

All lot numbers

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Czech Republic, Lebanon, United Arab Republic, Austria, Australia, Belgium, Bermuda, Canada, Switzerland, Chile, Colombia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Indonesia, Ireland, Italy, Luxembourg, Netherlands, Japan, Norway, Portugal, Saudi Arabia, Sweden, Belgium, Switzerland, Spain, China, Estonia, Hong Kong, Omen, Indonesia, Puerto Rico, Hungary, Israel, Singapore, Santa Domingo, New Zealand, Philippines, South Africa, Malaysia, and Lebanon

CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).STERILE EO, Smiths Medical ASD, Inc. || For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

Lot number 3308971

Anesthesiology Devices

2

No

INTERNATIONAL ONLY: GB, FR, AT, DE, IT, SE, IE, BE, ES, LU

UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ || The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no more than 30 days with an identical device. The range may include the following configurations: cuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning brushes and tracheostomy tube holder.

3297460,3297461 Model No. EL1915.  3297458,3297459,3297465, 3297466,3297467 Model No. SB5021.

General Hospital and Personal Use Devices

2

No

US Distribution to the state of : IN

Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.

a. Item No. 21-4474-24 (Lot No. 87X040, 87X117);  b. Item No. 21-4475-24 (Lot No. 87X044);  c. Item No. 21-4477-24 (Lot No. 87X097);  d. Item No. 21-8466-24 (Lot No. 87X171);  e. Item No. 21-8468-24 (Lot No. 87X172, 87X244, 87X180);  f. Item No. 21-8469-24 (Lot No. 87X151);  g. Item No. 21-8470-24 (Lot No. 87X173, 87X254, 87X194, 87X198, 87X237)

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.

Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: || a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); || b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); || c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); || d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); || e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); || f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); || g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)