FDA.reportPublic FDA data

Transystem™

Primary DI
28053326000588
Brand
Transystem™
Company
COPAN ITALIA SPA
Model
108C.USE
Catalog number
108C.USE
Device description
TRANSYSTEM AMIES W/O CH PLASTIC APPLICATOR RAYON TIPPED
Published
2022-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
38053326000585PackageGS110In Commercial Distribution
68053326000586PackageGS18In Commercial Distribution
28053326000588PrimaryGS10
18053326000581Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3805332600058538053326000585
6805332600058668053326000586
2805332600058828053326000588
1805332600058118053326000581

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.

Regulatory Flags#

DUNS number
428981112
Device count
50
Lot or batch
true
Expiration date on label
true

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
58053326002071 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
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