FDA.reportPublic FDA data

Sigma Transwab

Primary DI
05060259070457
Brand
Sigma Transwab
Company
MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED
Model
Amies
Catalog number
MW177S2ML
Device description
Sigma Transwab, Sigma swab ENT, 2 ml liquid amies
Published
2023-10-05
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
JTWSystem, Transport, Aerobic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTWSystem, Transport, AerobicMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060259070457PrimaryGS10
25060259070451Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060259070457050602590704575060259070457
2506025907045125060259070451

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
216096750
Device count
125
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060259072727Sigma TranswabSigma TranswabMW168S2024-03-15
05060259075476DryswabN/aMW112BP2023-10-06
25060259075470DryswabN/aMW112BP2023-10-06
05060259076206DryswabN/a3250052023-10-06
05060259070013TranswabAmiesMW169P2023-10-05
05060259070020TranswabCharcoalMW169C2023-10-05
05060259070037TranswabAmiesMW1702023-10-05
05060259070051TranswabCharcoalMW1712023-10-05
05060259070075TranswabPlainMW172P2023-10-05
05060259070082TranswabCharcoalMW172C2023-10-05
05060259070112TranswabPlainMW173P2023-10-05
05060259070129TranswabCharcoalMW173C2023-10-05
05060259070136TranswabPlain AmiesMW175P2023-10-05
05060259070143TranswabCharcoalMW175C2023-10-05
05060259070181Sigma TranswabAmiesMW167S2023-10-05
05060259070198Sigma TranswabAmiesMW176S2023-10-05
05060259070204Sigma TranswabAmiesMW176SE22023-10-05
05060259070211Sigma TranswabAmiesMW176S32023-10-05
05060259070242Sigma TranswabAmiesMW177S2023-10-05
05060259070273TranswabStuarts PlainMW165P2023-10-05

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
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
38053326000233eSwab™ COPAN ITALIA SPAJTW2023-06-14
38053326009526eSwab™ COPAN ITALIA SPAJTW2023-05-11
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
28053326000021eSwab™ COPAN ITALIA SPAJTW2022-12-07
28053326000144eSwab™ COPAN ITALIA SPAJTW2022-12-07
28053326000168eSwab™ COPAN ITALIA SPAJTW2022-12-07