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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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N/A - 00817827025099

150 mL Quad Aliquot Bag System
CHARTER MEDICAL, LTD.
T3000
In Commercial Distribution

  • 00817827025594 ()
  • 00817827025099 ()
T3000

  • Paediatric blood donor set

N/A - 00817827025082

150mL Six Bag Aliquot System with piercing pin
CHARTER MEDICAL, LTD.
T2186
In Commercial Distribution

  • 00817827025587 ()
  • 00817827025082 ()
T2186

  • Paediatric blood donor set

N/A - 00817827025075

150mL Triple Aliquot Bag System with piercing pin
CHARTER MEDICAL, LTD.
T2182
In Commercial Distribution

  • 00817827025570 ()
  • 00817827025075 ()
T2182

  • Paediatric blood donor set

N/A - 00817827025068

150mL Eight Bag Aliquot System with piercing pin unsegmented tubing
CHARTER MEDICAL, LTD.
T2008
In Commercial Distribution

  • 00817827025563 ()
  • 00817827025068 ()
T2008

  • Paediatric blood donor set

N/A - 00817827025051

600mL Bag with Needle Adapter AUTOLOGOUS TRANSFER SETS
CHARTER MEDICAL, LTD.
C605
In Commercial Distribution

  • 00817827025556 ()
  • 00817827025051 ()
  • 00817827025952 ()
C605

  • Blood/tissue storage/culture container

N/A - 00817827025044

600mL Bag with Piercing Pin AUTOLOGOUS TRANSFER SETS
CHARTER MEDICAL, LTD.
C600
In Commercial Distribution

  • 00817827025549 ()
  • 00817827025044 ()
  • 00817827025945 ()
C600

  • Blood/tissue storage/culture container

N/A - 00817827025037

Pooling Harness Set 10 Lead Harness Set
CHARTER MEDICAL, LTD.
T8010
In Commercial Distribution

  • 00817827025532 ()
  • 00817827025037 ()
T8010

  • Blood transfer set

N/A - 00817827025020

Pooling Harness Set 6 Lead Harness Set
CHARTER MEDICAL, LTD.
T8006
In Commercial Distribution

  • 00817827025525 ()
  • 00817827025020 ()
T8006

  • Blood transfer set

N/A - 00817827025013

150mL Six Bag Aliquot System With Peircinh Pin and Needless Syringe Adapter
CHARTER MEDICAL, LTD.
T2286
In Commercial Distribution

  • 00817827025518 ()
  • 00817827025013 ()
T2286

  • Paediatric blood donor set

Cell Freeze - 00817827023088

Cell Freeze Cryogenic Container Fill Range (50-90 mL)
CHARTER MEDICAL, LTD.
CML-75LN
In Commercial Distribution

  • 00817827023583 ()
  • 00817827023088 ()
CML-75LN

  • Blood/tissue storage/culture container

Cell Freeze - 00817827023064

Cell Freeze Cryogenic Storage Container 750 mL Capacity
CHARTER MEDICAL, LTD.
CF-750
In Commercial Distribution

  • 00817827023569 ()
  • 00817827023064 ()
CF-750

  • Blood/tissue storage/culture container

Cell Freeze - 00817827023057

Cell Freeze Cryogenic Storage Container 50 mL Capacity
CHARTER MEDICAL, LTD.
CF-50
In Commercial Distribution

  • 00817827023552 ()
  • 00817827023057 ()
CF-50

  • Blood/tissue storage/culture container

Cell Freeze - 00817827023040

Cell Freeze Cryogenic Storage Container 500 mL Capacity
CHARTER MEDICAL, LTD.
CF-500-3L
In Commercial Distribution

  • 00817827025457 ()
  • 00817827023040 ()
CF-500-3L

  • Blood/tissue storage/culture container

Cell Freeze - 00817827023033

Cell Freeze Cryogenic Storage Container 500 mL Capacity
CHARTER MEDICAL, LTD.
CF-500
In Commercial Distribution

  • 00817827023538 ()
  • 00817827023033 ()
CF-500

  • Blood/tissue storage/culture container

Cell Freeze - 00817827023026

Cell Freeze Cryogenic Storage Container 250 mL Capacity
CHARTER MEDICAL, LTD.
CF-250-3L
In Commercial Distribution

  • 00817827023521 ()
  • 00817827023026 ()
CF-250-3L

  • Blood/tissue storage/culture container

Cell Freeze - 00817827023019

Cell Freeze Cryogenic Storage Container 250 mL Capacity
CHARTER MEDICAL, LTD.
CF-250
In Commercial Distribution

  • 00817827023514 ()
  • 00817827023019 ()
CF-250

  • Blood/tissue storage/culture container

N/A - 00817827021152

Plasma Transfer Set 5mL Syringe with Tubing Assembly
CHARTER MEDICAL, LTD.
03-220-XL
In Commercial Distribution

  • 00817827021855 ()
  • 00817827021152 ()
  • 00817827021657 ()
03-220-XL

  • Blood transfer set

N/A - 00817827021145

Plasma/Fluid Transfer Set 100 mL Bag, 12 mL Syringe and Adapter Cap Assembly
CHARTER MEDICAL, LTD.
03-220-TMBC
In Commercial Distribution

  • 00817827021640 ()
  • 00817827021145 ()
03-220-TMBC

  • Blood transfer set

N/A - 00817827021138

Plasma/Fluid Transfer Set 12" tubing with needle assembly and 100mL bag
CHARTER MEDICAL, LTD.
03-220-TM
In Commercial Distribution

  • 00817827021633 ()
  • 00817827021138 ()
03-220-TM

  • Blood transfer set

N/A - 00817827021121

Plasma/Fluid Transfer Set with Tube Adapter
CHARTER MEDICAL, LTD.
03-220-BD
Not in Commercial Distribution

  • 00817827021626 ()
  • 00817827021121 ()
03-220-BD

  • Blood transfer set

N/A - 00817827021114

Plasma/Fluid Transfer Set 10ml Syringe and Adapter Cap Assembly
CHARTER MEDICAL, LTD.
03-220-BC
In Commercial Distribution

  • 00817827021619 ()
  • 00817827021114 ()
03-220-BC

  • Blood transfer set

N/A - 00817827021107

Plasma/Fluid Transfer Set 20ml Syringe and Adapter Cap
CHARTER MEDICAL, LTD.
03-220-BC-20
In Commercial Distribution

  • 00817827021107 ()
  • 00817827021602 ()
03-220-BC-20

  • Blood transfer set

N/A - 00817827021091

Plasma/Fluid Transfer Set 12mL Monoject™ Syringe and Adapter Cap Assembly
CHARTER MEDICAL, LTD.
03-220-BC12
In Commercial Distribution

  • 00817827021596 ()
  • 00817827021091 ()
03-220-BC12

  • Blood transfer set

N/A - 00817827021084

Plasma Transfer Set 2" Tubing with Male Luer Adapter
CHARTER MEDICAL, LTD.
03-220-94
In Commercial Distribution

  • 00817827021589 ()
  • 00817827021787 ()
  • 00817827021084 ()
03-220-94

  • Blood transfer set

N/A - 00817827021077

Plasma Transfer Sets 2" tubing with Pinch Clamp and Female Luer Adapter
CHARTER MEDICAL, LTD.
03-220-92
In Commercial Distribution

  • 00817827021572 ()
  • 00817827021770 ()
  • 00817827021077 ()
03-220-92

  • Blood transfer set

N/A - 00817827021060

Plasma Transfer Sets 4" tubing with female luer adapter
CHARTER MEDICAL, LTD.
03-220-90
In Commercial Distribution

  • 00817827021565 ()
  • 00817827021763 ()
  • 00817827021060 ()
03-220-90

  • Blood transfer set

N/A - 00817827021053

Plasma Transfer Sets Duel syringe adapters, entry port and piercing pin
CHARTER MEDICAL, LTD.
03-220-50
In Commercial Distribution

  • 00817827021756 ()
  • 00817827021053 ()
  • 00817827021558 ()
03-220-50

  • Blood transfer set

N/A - 00817827021046

Plasma Transfer Set 24" Tubing (61cm) with Needle Adapter
CHARTER MEDICAL, LTD.
03-220-30
In Commercial Distribution

  • 00817827021749 ()
  • 00817827021046 ()
  • 00817827021541 ()
  • 00817827021947 ()
03-220-30

  • Blood transfer set

N/A - 00817827021039

Plasma/Fluid Transfer Set with Adapter Cap and Tubing Assembly
CHARTER MEDICAL, LTD.
03-220-100
In Commercial Distribution

  • 00817827021039 ()
  • 00817827021534 ()
03-220-100

  • Blood transfer set

N/A - 00817827021022

Plasma/Fluid Transfer Set 24" Tubing with two piercing pins
CHARTER MEDICAL, LTD.
03-220-00
In Commercial Distribution

  • 00817827021725 ()
  • 00817827021022 ()
  • 00817827021923 ()
  • 00817827021527 ()
03-220-00

  • Blood transfer set

Celling ART PRP System - 00817771029983

ART PRP 2-Step Processing Kit
Celling Biosciences
1651-0001
In Commercial Distribution

  • 00817771029983 ()
1651-0001

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP 2-Step - 00817771029174

ART PRP 2-Step Device
Celling Biosciences
1601-0001
In Commercial Distribution

  • 00817771029174 ()
1601-0001

  • Haematological concentrate system preparation kit, platelet concentration

SpineSmith Fusionary Graft Delivery System - 00817771027613

ART GFC Kit
Celling Biosciences
0887-0001
In Commercial Distribution

  • 00817771027613 ()
0887-0001

  • Bone graft syringe, single-use

Celling ART PRP System - 00817771027569

ART PRP Plus Processing Kit
Celling Biosciences
0885-2000
In Commercial Distribution

  • 00817771027569 ()
0885-2000

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP System - 00817771027545

ART PRP Processing Kit
Celling Biosciences
0885-1000
In Commercial Distribution

  • 00817771027545 ()
0885-1000

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP System - 00817771027507

ART PRP Plus Device
Celling Biosciences
0865-0002
In Commercial Distribution

  • 00817771027507 ()
0865-0002

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP System - 00817771027491

ART PRP Device
Celling Biosciences
0885-0001
In Commercial Distribution

  • 00817771027491 ()
0885-0001

  • Haematological concentrate system preparation kit, platelet concentration

SpineSmith Fusionary Graft Delivery System - 00817771027392

120cc: Graft Delivery Kit
Celling Biosciences
0852-0120
In Commercial Distribution

  • 00817771027392 ()
0852-0120

  • Bone graft syringe, single-use

SpineSmith Fusionary Graft Delivery System - 00817771027323

BMA Kit Standard
Celling Biosciences
0851-0061
In Commercial Distribution

  • 00817771027323 ()
0851-0061

  • Bone graft syringe, single-use

Celling ART PRP 2-Step - 00817771029525

ART PRP 2-Step Device with SightWheel
Celling Biosciences
1601W-0001
In Commercial Distribution

  • 00817771029525 ()
1601W-0001

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP System - 00817771028887

ART PRP 2-Step - this is a duplicate. see 1601-0001 - UDI# 00817771029174
Celling Biosciences
1601-0001
Not in Commercial Distribution

  • 00817771028887 ()
Duplicate See 000817771029174

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP System - 00817771027552

ART PRP PLus Processing Kit
Celling Biosciences
0885-1060
In Commercial Distribution

  • 00817771027552 ()
0885-1060

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP System - 00817771027538

ART PRP Processing Kit
Celling Biosciences
0885-0060
In Commercial Distribution

  • 00817771027538 ()
0885-0060

  • Haematological concentrate system preparation kit, platelet concentration

SpineSmith Fusionary Graft Delivery System - 00817771027385

Graft Delivery Kit
Celling Biosciences
0852-0001
In Commercial Distribution

  • 00817771027385 ()
0852-0001

  • Bone graft syringe, single-use

SpineSmith Fusionary Graft Delivery System - 00817771027378

Blood Draw Kit
Celling Biosciences
0851-3060
In Commercial Distribution

  • 00817771027378 ()
0851-3060

  • Bone graft syringe, single-use

SpineSmith Fusionary Graft Delivery System - 00817771027361

Small Volume Bone Marrow Aspiration Kit
Celling Biosciences
0851-1070
In Commercial Distribution

  • 00817771027361 ()
0851-1070

  • Bone graft syringe, single-use

SpineSmith Fusionary Graft Delivery System - 00817771027354

Bone Marrow Aspiration Kit
Celling Biosciences
0851-1060
In Commercial Distribution

  • 00817771027354 ()
0851-1060

  • Bone graft syringe, single-use

SpineSmith Fusionary Graft Delivery System - 00817771027316

BMA Kit with 30cc Syringes
Celling Biosciences
0851-0030
In Commercial Distribution

  • 00817771027316 ()
0851-0030

  • Bone graft syringe, single-use

Chembio DPP HIV 1/2 Rapid Test Control Pack - 00607158000045

The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio DPP HIV 1/2 Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control) as described. One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.5mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9552-0
In Commercial Distribution

  • 00607158000045 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Clearview Complete HIV 1/2 - 00607158000021

The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9523-0
Not in Commercial Distribution

  • 00607158000021 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
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