FDA.reportPublic FDA data

Starswab Anaerobic Transport System

Primary DI
00840165400457
Brand
Starswab Anaerobic Transport System
Company
Pretium Canada Packaging ULC
Model
S120-5
Device description
Starswab Anaerobic Transport System, 5 ml Media Fill, Double Plastic Shaft Rayon Tip Swab Applicator.
Published
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840165400457PackageGS110In Commercial Distribution
00840165400440PrimaryGS10
10840165400447Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840165400457008401654004578401654004570840165400457
00840165400440008401654004408401654004400840165400440
1084016540044710840165400447

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kit IVD, clinicalA collection of in vitro diagnostic 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 in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246665038
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00840165401560Pinworm CollectorV302-PIN2025-10-07
10840165401185LeakbusterB602-1YN2025-04-29
10840165401406LeakbusterB602-1YNL2025-04-29
00840165400860StarplexV102-CA2025-04-29
10840165400867StarplexV102-CA2025-04-29
00840165401195LeakbusterB602-1YN2025-04-29
00840165401416LeakbusterB602-1YNL2025-04-29
10840165400966Starplex V302-F2025-03-04
10840165401062HistoplexH602-FL2025-03-04
00840165400976Starplex V302-F2025-03-04
00840165401072HistoplexH602-FL2025-03-04
00840165400266Starswab II Bacteriology Culture Collection and Transport SystemSP132-W2025-02-21
00840165400280Starswab II Bacteriology Culture Collection and Transport SystemSP132-FL2025-02-21
00840165400303Starswab II Bacteriology Culture Collection and Transport SystemSP130L2025-02-21
00840165400327Starswab II Bacteriology Culture Collection and Transport SystemSP130L-D2025-02-21
00840165400341Starswab II Bacteriology Culture Collection and Transport SystemSP130L-W2025-02-21
00840165400365Starswab Dry SwabS092025-02-21
00840165400389Starswab Dry SwabS09D2025-02-21
00840165400402Starswab Anaerobic Transport SystemS120-02025-02-21
00840165400426Starswab Anaerobic Transport SystemS120-D2025-02-21

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
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
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