X-VIVO 15 w/o PR and Gentamicine 1L bag BESP1457P1

GUDID 05407010124330

Lonza Verviers

Ex vivo cell culture medium
Primary Device ID05407010124330
NIH Device Record Key0968cf15-ab71-4f59-b782-75e32917cbe0
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-VIVO 15 w/o PR and Gentamicine 1L bag
Version Model NumberBESP1457P1
Catalog NumberBESP1457P1
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
GS105407010124330 [Primary]

FDA Product Code

JCFLymphocyte Separation Medium
KITMedia And Components, Synthetic Cell And Tissue Culture

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-03-03
Device Publish Date2022-12-09

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05407010129755 - Buffer G EZ-001 Module L : 1L Bag SAMPLE2025-12-31
05407010129762 - Buffer H EZ-001 Module L : 1L Bag SAMPLE2025-12-31
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