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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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Advect™ - 00817827026034

Fluid Transfer Sets 8 Lead Harness with Port Adapter
CHARTER MEDICAL, LTD.
CT-014-08
In Commercial Distribution

  • 00817827026539 ()
  • 00817827026034 ()
CT-014-08

  • Fluid transfer set, general-purpose

Advect™ - 00817827026027

Fluid Transfer Sets 6 Lead Harness with Port Adapter
CHARTER MEDICAL, LTD.
CT-014-06
In Commercial Distribution

  • 00817827026522 ()
  • 00817827026027 ()
CT-014-06

  • Fluid transfer set, general-purpose

Advect™ - 00817827026010

Fluid Transfer Sets 24" PVC with 2 Spike Adapters
CHARTER MEDICAL, LTD.
CT-014-00
In Commercial Distribution

  • 00817827026515 ()
  • 00817827026010 ()
CT-014-00

  • Fluid transfer set, general-purpose

N/A - 00817827025297

Plasma Pooling Set-1000mL Collection Bag w/(3) 400mL Aliquot Bags and Distal Needle Adapter
CHARTER MEDICAL, LTD.
T8703H
In Commercial Distribution

  • 00817827025792 ()
  • 00817827025297 ()
T8703H

  • Blood/tissue storage/culture container

N/A - 00817827025280

Pooling Harness Set 10 Lead Pooling Bag, 600mL Bag
CHARTER MEDICAL, LTD.
T6010
In Commercial Distribution

  • 00817827025785 ()
  • 00817827025280 ()
T6010

  • Blood/tissue storage/culture container

N/A - 00817827025273

400mL Transfer Bag with 5-Lead Tubing Assembly
CHARTER MEDICAL, LTD.
T4105
In Commercial Distribution

  • 00817827025778 ()
  • 00817827025273 ()
T4105

  • Blood/tissue storage/culture container

N/A - 00817827025266

Pooling Harness Set 6 Lead Pooling Bag 400mL
CHARTER MEDICAL, LTD.
T4006
In Commercial Distribution

  • 00817827025761 ()
  • 00817827025266 ()
T4006

  • Blood/tissue storage/culture container

N/A - 00817827025259

400mL Transfer Bag with 5 Lead Harness Set
CHARTER MEDICAL, LTD.
T4005
In Commercial Distribution

  • 00817827025754 ()
  • 00817827025259 ()
T4005

  • Blood/tissue storage/culture container

N/A - 00817827025242

Pooling harness Set 4 Lead Pooling Bag, 400mL
CHARTER MEDICAL, LTD.
T4004
In Commercial Distribution

  • 00817827025747 ()
  • 00817827025242 ()
T4004

  • Blood/tissue storage/culture container

N/A - 00817827025235

300mL Triple Aliquot System
CHARTER MEDICAL, LTD.
T3401
In Commercial Distribution

  • 00817827025730 ()
  • 00817827025235 ()
T3401

  • Blood/tissue storage/culture container

N/A - 00817827025228

400mL Triple Bag Aliquot System
CHARTER MEDICAL, LTD.
T3400
In Commercial Distribution

  • 00817827025723 ()
  • 00817827025228 ()
T3400

  • Blood/tissue storage/culture container

N/A - 00817827025211

Pooling Harness Set 4 Lead Harness Set with 400mL Bag
CHARTER MEDICAL, LTD.
T3194
In Commercial Distribution

  • 00817827025716 ()
  • 00817827025211 ()
T3194

  • Blood/tissue storage/culture container

N/A - 00817827025204

3000mL Bag
CHARTER MEDICAL, LTD.
T3110
In Commercial Distribution

  • 00817827025709 ()
  • 00817827025204 ()
T3110

  • Blood/tissue storage/culture container

N/A - 00817827025198

3000mL Transfer Bag with Peircing Pin
CHARTER MEDICAL, LTD.
T3109
In Commercial Distribution

  • 00817827025693 ()
  • 00817827025198 ()
  • 00817827025990 ()
T3109

  • Blood/tissue storage/culture container

N/A - 00817827025181

2000mL Transfer Pack with Peircing Pin
CHARTER MEDICAL, LTD.
T3108
In Commercial Distribution

  • 00817827025686 ()
  • 00817827025181 ()
  • 00817827025983 ()
T3108

  • Blood/tissue storage/culture container

N/A - 00817827025174

1000mL Transfer Pack with Peircing Pin
CHARTER MEDICAL, LTD.
T3107
In Commercial Distribution

  • 00817827025679 ()
  • 00817827025174 ()
  • 00817827025976 ()
T3107

  • Blood/tissue storage/culture container

N/A - 00817827025167

600mL - Double Aliquot Pack with piercing pin
CHARTER MEDICAL, LTD.
T3106X2
In Commercial Distribution

  • 00817827025662 ()
  • 00817827025167 ()
T3106X2

  • Blood/tissue storage/culture container

N/A - 00817827025129

Pooling Harness Set 6 Lead Pooling Bag, 3000mL
CHARTER MEDICAL, LTD.
T3006
In Commercial Distribution

  • 00817827025624 ()
  • 00817827025129 ()
T3006

  • Blood/tissue storage/culture container

N/A - 00817827025112

Transfer Pack - 150mL Quad (4) 150µ * Unsegmented Tubing
CHARTER MEDICAL, LTD.
T3003
In Commercial Distribution

  • 00817827025617 ()
  • 00817827025112 ()
T3003

  • Paediatric blood donor set

N/A - 00817827025105

150mL 2 Bag Aliquot Systen with piercing pin
CHARTER MEDICAL, LTD.
T3002
In Commercial Distribution

  • 00817827025600 ()
  • 00817827025105 ()
T3002

  • Paediatric blood donor set

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

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 - 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 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
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