m2000rt System m2000sp G-Series System m2000sp E-Series System

BCM SCC RAM

Shear Valve Assembly, used on CELL-DYN 3200, CELL-DYN 3500, CELL-DYN 3700, and CELL-DYN Ruby analyzers. Part nb: 8921204902 & 8921167602

Hematology Analyser

Product Name: ARCHITECT c4000, ARCHITECT c8000, ARCHITECT c16000. List Number: 2P24-01, 2P24-40, 1G06-11, 3L77-01 Instrument Serial Numbers: c460004 to c460014, c460016 to c460019, c400069, c400071 to c400099, c400146, c400219, c800307, c800742, c801237, c801462, c802378, c803060, c803061, c803062, c803063, c1600284

Processing Module System For In Vitro Diagnostic Use

List Number: 7D55-21 LOT: 71628UN10. List Number: 7D55-31 LOTS: 62474UN10 & 08145UN11.

IVD, Reagents

List Number: (1) 7K73-20 (2) 7K73-25 (3) 7K73-01 (4) 7K73-10 Serial/Lot Number (1) 11907JN01, 13909JN01, 15909JN01, 15916JN00, 18907JN01, 18907JN02, 21901JN01 (2) 11907JN00, 13909JN00, 15909JN00, 15916JN01, 18907JN00, 21901JN00, 21901JN03, 21901JN04 (3) 17342JN00, 19142JN00, 19142JN01, 19142JN02, 22270JN00, 23277JN00, 23277JN01 (4) 17203JN00, 19075JN00, 22121JN00, 23199JN00

Reagent Controls and Calibrators

ARCHITECT C-Peptide Reagent. List Number: 03L53-25, Lot Number: 03610K000, 00110L000, 01711A000, 01411B000, 00611E00 0

Reagents, Immunoassay, Therapeutic Drug

List Number 3P25-26 Lot Number 56940UI00

IVD, Reagent for Stat HsTN I

List Numbers: 6C29-20 and 6C29-25 Lot Numbers: See Attachment

IVD, Reagent

List Number 2K41-28, Lot 74264UN11

Reagents

List Number 3L52 (all lots) For lot number see attached

IVD, ARCHITECT 25-OH Vitamin D

List Number: 3L52-25 Lot Number: 01110L000

Reagents

List Number: 2K91-27, 2K91-20, 2K91-25 Lot Number: 08849M500, 08851M500, 08852M500, 08853M500, 10122M500, 10040M500

IVD, Reagent Kit

List Number (LN): 02P75‐01 .................................................... NCMDR Update code : Product Name : ( List Number ) - ARCHITECT c8000 Cuvette Segment : ( 01G46‐01 ) - ARCHITECT c16000 Cuvette Segment : ( 09D32‐05 )

Analyzers, Laboratory, Clinical Chemistry/Immunoassay

List Number: 6C19-25 Lot Numbers: 15070LI00 and 15070LI01

IVD, reagent

List Number: 1E08 Lot Number: 52803UN12, 62299UN12, 85773UN12 Expiration Date: See attached

IVD, Clinical Chemistry

List Number (LN) : 06P16‐01

Instrument

List number : 8L24-31 Lot Number : 60335Y600, 60382Y600 UDI Number : (01)00380740017682(17)180228, (10)60335Y600(240)8L2431, (01)00380740017682(17)180228, (10)60382Y600(240)8L2431 List Number : 8L24-41 Lot Number : 60334Y600 UDI number : 01)00380740017699(17)180228, (10)60334Y600(240)8L2441

List number : 8L24-31

ARCHITECT Cyclosporine List Number 1L75 (all in-date lots)

Assay, laboratory

Product Name : List Number : Lot Number AxSYM Valproic Acid Reagent : 07A71-20 : 18439M503

IVD, Reagent

Model: AR40e. Serial Numbers attached.

Intraocular lenses

STAR S4 IR Excimer Laser System, Software Versions 5.00 – 5.22.

Lasers, Excimer, Ophthalmic

Models 2, 3 and iFS

Optical, surgical, Laser

Lot Numbers: All lots up to and including Lot Number 783705 find attached Part Numbers

Catheter

Part Number : Description 1012587 : 018 HT CONNECT 145 CM 1012588 : 018 HT CONNECT 195 CM 1012589 : 018 HT CONNECT 300 CM 1012590 : 018 HT CONNECT FLEX 145 CM 1012591 : 018 HT CONNECT FLEX 195 CM 1012592 : 018 HT CONNECT FLEX 300 CM 1012593 : 018 HT CONNECT 250T 145 CM 1012594 : 018 HT CONNECT 250T 195 CM 1012595 : 018 HT CONNECT 250T 300 CM

Guide wires

CyberKnife® Robotic Radiosurgery Systems limited to certain G4, VSI, and G3 systems with the Cosmetic Appearance Package installed.

The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.