BHI BROTH 474CE.A

GUDID 28053326001028

BHI BROTH FOR AUTOMATION

COPAN ITALIA SPA

General specimen container IVD, additive/medium
Primary Device ID28053326001028
NIH Device Record Key4962f56c-871e-4d9b-935d-70d23051570c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBHI BROTH
Version Model Number474CE.A
Catalog Number474CE.A
Company DUNS428981112
Company NameCOPAN ITALIA SPA
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 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
GS108053326001024 [Unit of Use]
GS118053326001021 [Primary]
GS128053326001028 [Package]
Contains: 18053326001021
Package: [6 Units]
In Commercial Distribution

FDA Product Code

JSGCulture Media, Non-Selective And Non-Differential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-13
Device Publish Date2023-03-03

Devices Manufactured by COPAN ITALIA SPA

58053326009551 - Copan Universal Transport Medium (UTM-RT) System2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml
18053326009867 - Copan Universal Transport Medium (UTM-RT) System2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One flexible flocked swab, breaking point 100 mm
18053326010283 - Copan Universal Transport Medium (UTM-RT) System2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One regular flocked swab, breaking point 80 mm
08053326010446 - Copan Universal Transport Medium (UTM-RT) System2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3 ml
58053326011073 - Copan Universal Transport Medium (UTM-RT) System2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One minitip flocked swab, breaking point 80 mm
58053326011189 - Copan Universal Transport Medium (UTM-RT) System2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One regular flocked swab, breaking point 80 mm
18053326010405 - Copan Universal Transport Medium (UTM-RT) System2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One progressive flocked swab, breaking point 80 mm
58053326011714 - UriSponge™2025-03-20 UriSponge™ - Urine Collection, Transport, and Preservation System 100mm lenght x 16mm diameter

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