LabChoice Sputum Containers, 40 mL

GUDID 00810180842211

Non-Sterile

Dynarex Corporation

General specimen container IVD, no additive/medium
Primary Device ID00810180842211
NIH Device Record Keydce08638-6120-428d-959f-780547b52936
Commercial Distribution StatusIn Commercial Distribution
Brand NameLabChoice Sputum Containers, 40 mL
Version Model Number43000
Company DUNS008124539
Company NameDynarex Corporation
Device Count50
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
GS100810180842211 [Unit of Use]
GS100840117333383 [Package]
Contains: 00840117333437
Package: Case [8 Units]
In Commercial Distribution
GS100840117333437 [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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