Custom M199 w/o PR w/U1, Pluronic-1L Bot BESP1674Q-4

GUDID 05407010129830

Lonza Verviers

Cell culture buffered saline solution
Primary Device ID05407010129830
NIH Device Record Key98198e21-f116-4dc0-a86f-9f7efeb2f891
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom M199 w/o PR w/U1, Pluronic-1L Bot
Version Model NumberBESP1674Q-4
Catalog NumberBESP1674Q-4
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
GS105407010129830 [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 Date2025-12-31
Device Publish Date2025-12-23

Devices Manufactured by Lonza Verviers

05407010129700 - AA-5: 0.4 M Acetic Acid -500L Bag2025-12-31
05407010129717 - Buffer C EZ-001 Module L : 1L Bag SAMPLE2025-12-31
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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