N/A T8703H

GUDID 00817827025792

Plasma Pooling Set-1000mL Collection Bag w/(3) 400mL Aliquot Bags and Distal Needle Adapter

CHARTER MEDICAL, LTD.

Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container
Primary Device ID00817827025792
NIH Device Record Key2e1f18fa-9083-49cb-a668-f9dc2eddc18f
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberT8703H
Catalog NumberT8703H
Company DUNS029062325
Company NameCHARTER MEDICAL, LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(866) 458-3116
EmailCML_CustomerService@CharterMedical.com
Phone(866) 458-3116
EmailCML_CustomerService@CharterMedical.com
Phone(866) 458-3116
EmailCML_CustomerService@CharterMedical.com
Phone(866) 458-3116
EmailCML_CustomerService@CharterMedical.com
Phone(866) 458-3116
EmailCML_CustomerService@CharterMedical.com
Phone(866) 458-3116
EmailCML_CustomerService@CharterMedical.com
Phone(866) 458-3116
EmailCML_CustomerService@CharterMedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817827025297 [Primary]
GS100817827025792 [Package]
Contains: 00817827025297
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [N/A]

00817827025792Plasma Pooling Set-1000mL Collection Bag w/(3) 400mL Aliquot Bags and Distal Needle Adapter
00817827025785Pooling Harness Set 10 Lead Pooling Bag, 600mL Bag
00817827025778400mL Transfer Bag with 5-Lead Tubing Assembly
00817827025761Pooling Harness Set 6 Lead Pooling Bag 400mL
00817827025754400mL Transfer Bag with 5 Lead Harness Set
00817827025747Pooling harness Set 4 Lead Pooling Bag, 400mL
00817827025730300mL Triple Aliquot System
00817827025723400mL Triple Bag Aliquot System
00817827025716Pooling Harness Set 4 Lead Harness Set with 400mL Bag
008178270257093000mL Bag
008178270256933000mL Transfer Bag with Peircing Pin
008178270256862000mL Transfer Pack with Peircing Pin
008178270256791000mL Transfer Pack with Peircing Pin
00817827025662600mL - Double Aliquot Pack with piercing pin
00817827025655600mL Transfer Pack with Piercing Pin
00817827025648400mL Transfer Bag With Piercing Pin
00817827025631150mL TRANSFER BAG WITH PIERCING PIN
00817827025624Pooling Harness Set 6 Lead Pooling Bag, 3000mL
00817827025617Transfer Pack - 150mL Quad (4) 150µ * Unsegmented Tubing
00817827025600150mL 2 Bag Aliquot Systen with piercing pin
00817827025594150 mL Quad Aliquot Bag System
00817827025587150mL Six Bag Aliquot System with piercing pin
00817827025570150mL Triple Aliquot Bag System with piercing pin
00817827025563150mL Eight Bag Aliquot System with piercing pin unsegmented tubing
00817827025556600mL Bag with Needle Adapter AUTOLOGOUS TRANSFER SETS
00817827025549600mL Bag with Piercing Pin AUTOLOGOUS TRANSFER SETS
00817827025532Pooling Harness Set 10 Lead Harness Set
00817827025525Pooling Harness Set 6 Lead Harness Set
00817827025518150mL Six Bag Aliquot System With Peircinh Pin and Needless Syringe Adapter
00817827024559Neonatal/Pediatric Syringe Set 40µ Filter with 60cc Syringe
00817827024542Neonatal/Pediatric Syringe Set 40µ Filter with 35cc Monoject® Syringe
00817827024535Neonatal/Pediatric Syringe Set 40µ Filter with Syringe Adapter
00817827024528Neonatal/Pediatric Syringe Set 40µ Filter with 60cc Syringe
00817827024511Neonatal/Pediatric Syringe Set 40µ Filter with 30cc Sryinge
00817827022715Neonatal/Pediatric Syringe Set 150µ Filter, 60cc Syringe, 150mL bag
00817827022708Neonatal/Pediatric Syringe Set 150µ Filter, 60cc Syringe, 150mL bag
00817827022692Neonatal/Pediatric Syringe Set 150µ Filter, 60cc Syringe, 150mL bag
00817827022685Neonatal/Pediatric Syringe Set 150µ Filter, 30cc Syringe, 150 mL bag
00817827022678Neonatal/Pediatric Transfer Set 150µ filter and syringe adapters
00817827022654Neonatal/Pediatric Syringe Set 150µm filter and 60cc syringe. Not Manufactured with DEHP
00817827022647Neonatal/Pediatric Syringe Set 150µm filter and 60cc syringe. Not Manufactured with DEHP
00817827022630Neonatal/Pediatric Syringe Set 150µ filter and 60cc syringe
00817827022623Neonatal/Pediatric Syringe Set 150µ filter and 35cc syringe; not manufactured with DEHP
00817827022616Neonatal/Pediatric Syringe Set 150µ and 35cc syringe
00817827022609Neonatal/Pediatric Syringe Set 150µ filter and port adapter
00817827022593Neonatal/Pediatric Syringe Set: 150µ filter and Syringe Adapter; not manufactured with DEHP
00817827022586Neonatal/Pediatric Transfer Set 150µ filter and syringe adapter
00817827022579Neonatal/Pediatric Syringe Set 150µ filter and syringe adapter
00817827022562Neonatal/Pediatric Syringe Set 150µ and 60cc syringe
00817827022555Neonatal/Pediatric Syringe Set: 150µ filter and 60cc syringe. Not Manufactured with DEHP
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