Lactate Gen.2 5401666190

GUDID 04015630926954

Roche Diagnostics GmbH

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Primary Device ID04015630926954
NIH Device Record Key7e85bb76-f40f-4c81-bd01-203dae6d1a0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLactate Gen.2
Version Model Number5401666190
Catalog Number5401666190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630926954 [Primary]

FDA Product Code

KHPACID, LACTIC, ENZYMATIC METHOD

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-26
Device Publish Date2021-01-18

On-Brand Devices [Lactate Gen.2]

0761333612135108057940190
040156309269545401666190
040156309251485171881190
040156309189113183700190

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