BBL™ CultureSwab™ 220109

GUDID 58053326001883

CultureSwab Liquid Stuart Double Swab

COPAN ITALIA SPA

General specimen collection kit
Primary Device ID58053326001883
NIH Device Record Key0c67824c-18eb-4758-9f89-b9453c7925e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBBL™ CultureSwab™
Version Model Number220109
Catalog Number220109
Company DUNS428981112
Company NameCOPAN ITALIA SPA
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
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
GS118053326001885 [Unit of Use]
GS138053326001889 [Primary]
GS158053326001883 [Package]
Contains: 38053326001889
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSMCulture Media, Non-Propagating Transport

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

On-Brand Devices [BBL™ CultureSwab™ ]

58053326002095CultureSwab Sterile Double Swab
58053326002088CultureSwab Sterile Single Swab
58053326002019CultureSwab Cary-Blair Agar Single Swab
58053326002002CultureSwab Stuart Flexible Wire
58053326001999CultureSwab Stuart
58053326001982CultureSwab Stuart Soft Wire
58053326001975CultureSwab Liquid Stuart Single Swab
58053326001968CultureSwab Amies Flexible Wire
58053326001951CultureSwab Amies Soft Wire
58053326001944CultureSwab Amies
58053326001937CultureSwab Liquid Amies Single Swab
58053326001883CultureSwab Liquid Stuart Double Swab
58053326001876CultureSwab Liquid Amies Double Swab

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