FDA.reportPublic FDA data

CultureSwab™ MaxV(+)

Primary DI
58053326002071
Brand
CultureSwab™ MaxV(+)
Company
COPAN ITALIA SPA
Model
220236
Catalog number
220236
Device description
MaxV(+) CULTURE SWAB MAXV(+) DUAL AMIES W/O CH TWO PLASTIC RAYON Amies Gel w/o Charcoal Double Plastic Applicators
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JSLCulture Media, Anaerobic Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSLCulture Media, Anaerobic TransportMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972448000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972448000COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOALCopan Italia Spa1997-08-20JSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
58053326002071PackageGS110In Commercial Distribution
38053326002077PrimaryGS10
18053326002073Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5805332600207158053326002071
3805332600207738053326002077
1805332600207318053326002073

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kitA collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428981112
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
38053326007027FLOQSwabs®53380CS0153380CS012026-03-20
58053326007021FLOQSwabs®53380CS0153380CS012026-03-20
38053326011826BD FCT4453884453882026-01-26
58053326011820BD FCT4453884453882026-01-26
38053326011598UTM®3C098N3C098N2024-11-13
38053326011604UTM® 3C099N01 3C099N01 2024-11-13
38053326011611UTM® 3C100N013C100N012024-11-13
38053326011796FLOQSwabs®5U200S01.BD5U200S01.BD2025-10-01
38053326008420UTM® 3C042N3C042N2022-12-13
38053326011772LBM CABroth4U161N4U161N2025-09-22
08053326011771LBM CABroth4U161N4U161N2025-09-22
58053326011653CLASSIQSwab10494425001104944250012025-07-03
58053326011660CLASSIQSwabs™ FLOQ Swabs® 10494417001104944170012025-07-03
38053326011710UriSponge™8U033S508U033S502025-03-12
38053326009557Copan Universal Transport Medium (UTM-RT) System3C047N3C047N2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) System3C057N3C057N2025-05-28
38053326010287Copan Universal Transport Medium (UTM-RT) System3C064N3C064N2025-05-28
38053326010447Copan Universal Transport Medium (UTM-RT) System3C075N3C075N2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) System3C085N013C085N012025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) System3C088N013C085N012025-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840165400402Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400426Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400440Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400419Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400433Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00840165400457Starswab Anaerobic Transport SystemPretium Canada Packaging ULCJSL2025-02-21
00842558116419ACT I Transport PK/10REMEL, INC.JSL2024-08-06
00842558116426ACT II Transport PK/10REMEL, INC.JSL2024-08-06
00842558116433ACT II Dual Transport PK/10REMEL, INC.JSL2024-08-06
38053326002077 CultureSwab™ MaxV(+)COPAN ITALIA SPAJSL2023-06-14
38053326001919BD BBL ™ CultureSWAB ™ COPAN ITALIA SPAJSL2023-03-03
38053326009823Transystem™ COPAN ITALIA SPAJSL2023-03-03
58053326001913BD BBL ™ CultureSWAB ™ COPAN ITALIA SPAJSL2023-03-03
58053326009827Transystem™ COPAN ITALIA SPAJSL2023-03-03
28053326000588Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326000595Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326000601Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326000861Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326001219Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326001578Transystem™ COPAN ITALIA SPAJSL2022-12-07
28053326004913Transystem™ COPAN ITALIA SPAJSL2022-12-07
38053326001605BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001827BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001834BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001841BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001858BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001865BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001896BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001902BBL™ CultureSwab™ PlusCOPAN ITALIA SPAJSL2022-12-07
38053326001926BBL™ CultureSwab™ Plus COPAN ITALIA SPAJSL2022-12-07