Buffer FCM-H2 - 1000L Bag

GUDID 05407010124798

Lonza Verviers

Cell culture medium IVD
Primary Device ID05407010124798
NIH Device Record Keyc8376ec5-1440-41fc-9321-d8f84432cf53
Commercial Distribution StatusIn Commercial Distribution
Brand NameBuffer FCM-H2 - 1000L Bag
Version Model NumberBESP1577P1000
Company DUNS370158847
Company NameLonza Verviers
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105407010124798 [Primary]

FDA Product Code

KITMedia And Components, Synthetic Cell And Tissue Culture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-05
Device Publish Date2023-04-27

Devices Manufactured by Lonza Verviers

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05407010129724 - Buffer D EZ-001 Module L : 1L Bag SAMPLE2025-12-31
05407010129731 - Buffer E1 EZ-001 Module L : 1L Bag2025-12-31
05407010129748 - Buffer E1 EZ-001 Module L: 1L Bag SAMPLE2025-12-31
05407010129755 - Buffer G EZ-001 Module L : 1L Bag SAMPLE2025-12-31
05407010129762 - Buffer H EZ-001 Module L : 1L Bag SAMPLE2025-12-31
05407010129779 - Buffer I EZ-001 Module L : 1L Bag2025-12-31

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