LabChoice Pet Cell Bottle, 1000 mL

GUDID 00840117337381

Dynarex Corporation

General specimen container IVD, no additive/medium
Primary Device ID00840117337381
NIH Device Record Keyf35d13bb-33bc-4fd6-9dad-cf1e874b9eb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameLabChoice Pet Cell Bottle, 1000 mL
Version Model Number43152
Company DUNS008124539
Company NameDynarex Corporation
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117329577 [Package]
Package: Case [48 Units]
In Commercial Distribution
GS100840117337381 [Primary]

FDA Product Code

NNIContainer, Specimen, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-24
Device Publish Date2025-06-16

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