FDA.reportPublic FDA data

Starswab Dry Swab

Primary DI
00840165400389
Brand
Starswab Dry Swab
Company
Pretium Canada Packaging ULC
Model
S09D
Device description
Double standard plastic shaft rayon tip swab applicator in tube.
Published
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840165400396PackageGS15In Commercial Distribution
00840165400389PrimaryGS10
10840165400386Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840165400396008401654003968401654003960840165400396
00840165400389008401654003898401654003890840165400389
1084016540038610840165400386

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.

Regulatory Flags#

DUNS number
246665038
Device count
100
Premarket exempt
true

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
00840165400402Starswab Anaerobic Transport SystemS120-02025-02-21
00840165400426Starswab Anaerobic Transport SystemS120-D2025-02-21
00840165400440Starswab Anaerobic Transport SystemS120-52025-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
38053326007027FLOQSwabs®COPAN ITALIA SPAKXG2026-03-20
08809262391039Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391053Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391060Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391077Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391329Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391336Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391343Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391350Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391367Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391374Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391527Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391534Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262392104Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394030Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394047Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394061Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394078Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394085Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394092Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394115Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394122Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394139Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394146Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394153Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394177Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394191Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394207Specimen Collection swabHLB CO.,LTDKXG2025-10-28
08809262394214Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394221Specimen Collection SwabHLB CO.,LTDKXG2025-10-28