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

  • 00817827025594 ()
  • 00817827025099 ()
T3000

  • Paediatric blood donor set
150mL Six Bag Aliquot System with piercing pin
CHARTER MEDICAL, LTD.
T2186
In Commercial Distribution

  • 00817827025587 ()
  • 00817827025082 ()
T2186

  • Paediatric blood donor set
150mL Triple Aliquot Bag System with piercing pin
CHARTER MEDICAL, LTD.
T2182
In Commercial Distribution

  • 00817827025570 ()
  • 00817827025075 ()
T2182

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

  • 00817827025563 ()
  • 00817827025068 ()
T2008

  • Paediatric blood donor set
600mL Bag with Needle Adapter AUTOLOGOUS TRANSFER SETS
CHARTER MEDICAL, LTD.
C605
In Commercial Distribution

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

  • Blood/tissue storage/culture container
600mL Bag with Piercing Pin AUTOLOGOUS TRANSFER SETS
CHARTER MEDICAL, LTD.
C600
In Commercial Distribution

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

  • Blood/tissue storage/culture container
Pooling Harness Set 10 Lead Harness Set
CHARTER MEDICAL, LTD.
T8010
In Commercial Distribution

  • 00817827025532 ()
  • 00817827025037 ()
T8010

  • Blood transfer set
Pooling Harness Set 6 Lead Harness Set
CHARTER MEDICAL, LTD.
T8006
In Commercial Distribution

  • 00817827025525 ()
  • 00817827025020 ()
T8006

  • Blood transfer set
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 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 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 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 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 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 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 Cryogenic Storage Container 250 mL Capacity
CHARTER MEDICAL, LTD.
CF-250
In Commercial Distribution

  • 00817827023514 ()
  • 00817827023019 ()
CF-250

  • Blood/tissue storage/culture container
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
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
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
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
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
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
ART PRP 2-Step Device
Celling Biosciences
1601-0001
In Commercial Distribution

  • 00817771029174 ()
1601-0001

  • Haematological concentrate system preparation kit, platelet concentration
ART GFC Kit
Celling Biosciences
0887-0001
In Commercial Distribution

  • 00817771027613 ()
0887-0001

  • Bone graft syringe, single-use
ART PRP Plus Processing Kit
Celling Biosciences
0885-2000
In Commercial Distribution

  • 00817771027569 ()
0885-2000

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP Processing Kit
Celling Biosciences
0885-1000
In Commercial Distribution

  • 00817771027545 ()
0885-1000

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP Plus Device
Celling Biosciences
0865-0002
In Commercial Distribution

  • 00817771027507 ()
0865-0002

  • Haematological concentrate system preparation kit, platelet concentration
No Description
Biosafe S.A.
CryoSC-D Seal positioner
Not in Commercial Distribution

  • 07640125650563 ()
7026

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
Metal Storage Canister
In Commercial Distribution

  • 07640125650549 ()
  • 07640125650532 ()
  • 07640125650631 ()
7012

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
Traceability Labels for Bioarchive
Not in Commercial Distribution

  • 07640125650501 ()
7031

  • Blood centrifugation system containment kit
NDDR version 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution

  • 00812747010217 ()


  • Clinical laboratory information system application software
Donor Doc version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010200 ()


  • Configurable electronic form web-based application software
Symphony version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010194 ()


  • Blood bank information system application software
Surround version 5.x.x
HAEMONETICS CORPORATION
5.x.x
In Commercial Distribution

  • 00812747010170 ()


  • Blood bank information system application software
ElDorado Donor version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010149 ()


  • Blood bank information system application software
ElDorado Donor 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution

  • 00812747010132 ()


  • Blood bank information system application software
McKesson Blood Bank version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010118 ()


  • Blood bank information system application software
InstaMatch version 1.X.X
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution

  • 00812747010088 ()


  • Blood bank information system application software
CDCS version 1.x.x
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution

  • 00812747010064 ()


  • Clinical laboratory information system application software
NextGen version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010057 ()


  • Blood bank information system application software
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