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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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DonorCare® Needle Guard Small Channel - 19555240400137

DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
ITL ASIA PACIFIC SDN. BHD.
A100100
In Commercial Distribution

  • 09555240400130 ()
  • 19555240400137 ()
A100100

  • Needle guard

AcroMetrix BB NAT HCV Positive Control - 00884883005921

No Description
Microgenics Corporation
963601
In Commercial Distribution

  • 00884883005921 ()


  • Hepatitis C virus antibody/antigen IVD, control

AcroMetrix BB NAT WNV Negative Control - 00884883005907

No Description
Microgenics Corporation
960600
Not in Commercial Distribution

  • 00884883005907 ()


  • West Nile virus nucleic acid IVD, control

AcroMetrix BB NAT Negative Control - 00884883005945

No Description
Microgenics Corporation
963600
In Commercial Distribution

  • 00884883005945 ()


  • PCR/NAT negative control IVD

Acrometrix BB NAT HIV-1 POS. CTRL - 00884883005891

No Description
Microgenics Corporation
963602
In Commercial Distribution

  • 00884883005891 ()


  • HIV1 nucleic acid IVD, control

SCD Welding Wafer - 35020583260314

3-NCC987 SCD Wafer
TERUMO BCT, INC.
3NCC987
In Commercial Distribution

  • 55020583260318 ()
  • 35020583260314 ()
  • 05020583260313 ()


  • Package sealing unit

SoftID.Tx - 00810055812257

No Description
SCC SOFT COMPUTER
1.0.0.18
In Commercial Distribution

  • 00810055812257 ()


  • Bedside information system application software

SoftBank - 00810055810727

No Description
SCC SOFT COMPUTER
25.5.6.2
In Commercial Distribution

  • 00810055810727 ()


  • Blood bank information system application software

HemoCue® Plasma/Low Hb Photometer - 07311091203144

HemoCue Plasma/Low Hb Photometer mg/dL
Hemocue AB
120314
In Commercial Distribution

  • 07311091203144 ()
120314

  • Haemoglobin analyser IVD, point-of-care

Ranger™ - 50707387781922

3M™ Ranger™ Hose Cap, 12 per Case, 90026
3M COMPANY
90026
In Commercial Distribution

  • 50707387781922 ()
  • 00707387781927 ()
90026

  • Conduction blood/fluid warmer set

PreciControl Syphilis - 07613336183175

Syphilis PC Elecsys
Roche Diagnostics GmbH
06923364162
In Commercial Distribution

  • 07613336183175 ()
06923364162

  • Treponema pallidum total antibody IVD, control

PreciControl Anti-CMV - 07613336183151

No Description
Roche Diagnostics GmbH
04784600162
In Commercial Distribution

  • 07613336183151 ()
04784600162

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

Elecsys Syphilis - 07613336183083

No Description
Roche Diagnostics GmbH
09015051162
In Commercial Distribution

  • 07613336228463 ()
  • 07613336183083 ()
09015051162

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

Elecsys Anti-CMV - 07613336183069

No Description
Roche Diagnostics GmbH
09118551162
In Commercial Distribution

  • 07613336228449 ()
  • 07613336183069 ()
09118551162

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, kit, chemiluminescent immunoassay

PreciControl Release Syphilis - 07613336183007

PreciControl Release Syphilis
Roche Diagnostics GmbH
09366903190
In Commercial Distribution

  • 07613336183007 ()
09366903190

  • Treponema pallidum total antibody IVD, control

PreciControl Release Anti-CMV - 07613336182987

No Description
Roche Diagnostics GmbH
09366679190
In Commercial Distribution

  • 07613336182987 ()
09366679190

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, control

Elecsys HIV combi PT - 07613336170212

No Description
Roche Diagnostics GmbH
08924180160
In Commercial Distribution

  • 07613336170212 ()
08924180160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Elecsys HIV combi PT - 07613336170182

No Description
Roche Diagnostics GmbH
08924163160
In Commercial Distribution

  • 07613336170182 ()
08924163160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

MCS 9000 - 30812747012861

No Description
HAEMONETICS CORPORATION
09000-220-ED
In Commercial Distribution

  • 30812747012861 ()


  • Apheresis system

HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM - 30812747012816

MCS+ ,110V ENGL, LN 09000-110-E
HAEMONETICS CORPORATION
09000-110-E
In Commercial Distribution

  • 30812747012816 ()


  • Apheresis system

HAEMONETICS PCS 2 APHERESIS SYSTEM - 30812747011963

PCS2, LIST NO. 06002-220-EXP-EW
HAEMONETICS CORPORATION
06002-220-EXP-EW
In Commercial Distribution

  • 30812747011963 ()


  • Autotransfusion system blood component processing set

HAEMONETICS PCS 2 APHERESIS SYSTEM - 30812747011833

PCS2, LIST NO, LN06002-CP-220-EW
HAEMONETICS CORPORATION
06002-CP-220-EW
In Commercial Distribution

  • 30812747011833 ()


  • Autotransfusion system blood component processing set

HAEMONETICS PCS 2 APHERESIS SYSTEM - 30812747011819

PCS2,LIST NO,LN06002-110-NA-EW
HAEMONETICS CORPORATION
06002-110-NA-EW
In Commercial Distribution

  • 30812747011819 ()


  • Autotransfusion system blood component processing set

Haemonetics® NexSys PCS® System - 30812747019808

Persona™ Plasma Pooling Bottles
HAEMONETICS CORPORATION
0699S-12
In Commercial Distribution

  • 00812747019807 ()
  • 30812747019808 ()


  • Apheresis system tubing set

ACP 215 - 30812747015183

UNIT PACK ASSY,SHAKER,ACP215
HAEMONETICS CORPORATION
50042-00
In Commercial Distribution

  • 30812747015183 ()


  • Blood cell freeze/thaw system

HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM - 30812747012878

MCS+, 220V, LN09000-220-EW-RU
HAEMONETICS CORPORATION
09000-220-EW
In Commercial Distribution

  • 30812747012878 ()


  • Apheresis system

HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM - 30812747012854

MCS+, 220V ENGL, LN 09000-220-E
HAEMONETICS CORPORATION
09000-220-E
In Commercial Distribution

  • 30812747012854 ()


  • Apheresis system

HAEMONETICS PCS 2 APHERESIS SYSTEM - 30812747011987

PCS2, LN, 06002-110-EXS-EW
HAEMONETICS CORPORATION
06002-110-EXS-EW
In Commercial Distribution

  • 30812747011987 ()


  • Autotransfusion system blood component processing set

HAEMONETICS PCS 2 APHERESIS SYSTEM - 30812747011956

PCS2, LIST NO. 06002-220-EXP
HAEMONETICS CORPORATION
06002-220-EXP
In Commercial Distribution

  • 30812747011956 ()


  • Autotransfusion system blood component processing set

HAEMONETICS PCS 2 APHERESIS SYSTEM - 30812747011840

PCS2, LIST NO. 06002-CP-220, RU
HAEMONETICS CORPORATION
06002-CP-220-RU
In Commercial Distribution

  • 30812747011840 ()


  • Autotransfusion system blood component processing set
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