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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 - 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
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