CultureSwab™ MaxV(+) 220235

GUDID 58053326002064

CultureSwab™ MaxV(+) Amies Gel w/o Charcoal Single Plastic Applicators

COPAN ITALIA SPA

General specimen collection kit
Primary Device ID58053326002064
NIH Device Record Key4c7ebcae-797a-4519-a514-5e95d4a0dd78
Commercial Distribution StatusIn Commercial Distribution
Brand NameCultureSwab™ MaxV(+)
Version Model Number220235
Catalog Number220235
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
GS118053326002066 [Unit of Use]
GS138053326002060 [Primary]
GS158053326002064 [Package]
Contains: 38053326002060
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSLCulture Media, Anaerobic 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 [ CultureSwab™ MaxV(+)]

58053326002064CultureSwab™ MaxV(+) Amies Gel w/o Charcoal Single Plastic Applicators
58053326002071MaxV(+) CULTURE SWAB MAXV(+) DUAL AMIES W/O CH TWO PLASTIC RAYON Amies Gel w/o Charcoal Double

Trademark Results [CultureSwab]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CULTURESWAB
CULTURESWAB
78486418 3011481 Live/Registered
Becton, Dickinson and Company
2004-09-20

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