FDA.reportPublic FDA data

eSwab™

Primary DI
38053326005368
Brand
eSwab™
Company
COPAN ITALIA SPA
Model
493C02
Catalog number
493C02
Device description
1 LQ AMIES TEST TUBE + 1 PINK APPLICATORS + 1 WHITE APPLICATOR
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
JTWSystem, Transport, Aerobic
JTXTransport Systems, Anaerobic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTWSystem, Transport, AerobicMicrobiology1
JTXTransport Systems, AnaerobicMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
58053326005362PackageGS110In Commercial Distribution
68053326005369PackageGS18In Commercial Distribution
38053326005368PrimaryGS10
18053326005364Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5805332600536258053326005362
6805332600536968053326005369
3805332600536838053326005368
1805332600536418053326005364

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
00661392055650LSL HEALTHCARELSL Industries, LLCJTW2025-06-06
30382902900208BD Sputum Collection SystemBECTON, DICKINSON AND COMPANYJTW2024-11-19
00382902900207BD Sputum Collection SystemBECTON, DICKINSON AND COMPANYJTW2024-11-19
30382903649908BD Vacutainer® Urinalysis Transfer Straw KitBECTON, DICKINSON AND COMPANYJTW2024-04-10
50382903649902BD Vacutainer® Urinalysis Transfer Straw KitBECTON, DICKINSON AND COMPANYJTW2024-04-10
30382903649441BD Vacutainer® C&S Boric Acid KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
30382903649595BD Vacutainer® C&S Boric Acid KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
30382903649915BD Vacutainer® Urinalysis Transfer Straw KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
50382903649445BD Vacutainer® C&S Boric Acid KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
50382903649599BD Vacutainer® C&S Boric Acid KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
50382903649919BD Vacutainer® Urinalysis Transfer Straw KitBECTON, DICKINSON AND COMPANYJTW2024-04-09
50382903649759BD Vacutainer® Urine Collection CupsBECTON, DICKINSON AND COMPANYJTW2024-04-05
00382903649570BD Vacutainer® Urine Complete Cup KitBECTON, DICKINSON AND COMPANYJTW2024-04-05
50382903649575BD Vacutainer® Urine Complete Cup KitBECTON, DICKINSON AND COMPANYJTW2024-04-05
00382903649754BD Vacutainer® Urine Collection CupsBECTON, DICKINSON AND COMPANYJTW2024-04-05
05060259070457Sigma TranswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDJTW2023-10-05
05060259076046Sigma TranswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDJTW2023-10-05
25060259070451Sigma TranswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDJTW2023-10-05
15060259076043Sigma TranswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDJTW2023-10-05
30382903650171BD Vacutainer® Urinalysis Preservative Urine TubeBECTON, DICKINSON AND COMPANYJTW2023-09-08
28053326000236eSwab™ COPAN ITALIA SPAJTW2023-06-14
28053326000236eSwab™ COPAN ITALIA SPAJTX2023-06-14
38053326000233eSwab™ COPAN ITALIA SPAJTW2023-06-14
38053326009526eSwab™ COPAN ITALIA SPAJTW2023-05-11
38053326009526eSwab™ COPAN ITALIA SPAJTX2023-05-11
68053326009527eSwab™ COPAN ITALIA SPAJTW2023-05-11
50382903649667BD Vacutainer® Urine Transfer StrawBECTON, DICKINSON AND COMPANYJTW2023-03-15
30382903649434BD Vacutainer® Urinalysis Transfer Straw KitBECTON, DICKINSON AND COMPANYJTW2023-03-15
30382903649663BD Vacutainer® Urine Transfer StrawBECTON, DICKINSON AND COMPANYJTW2023-03-15
28053326000014eSwab™ COPAN ITALIA SPAJTW2022-12-07