FDA.reportPublic FDA data

Fisherbrand

Primary DI
30613647008738
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
1490721
Catalog number
1490721
Device description
SWAB LIQ STUARTS DBL FB 50/PK
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647008731PackageGS11In Commercial Distribution
30613647008738PackageGS110In Commercial Distribution
00613647008737PrimaryGS10
10613647008734Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364700873120613647008731
3061364700873830613647008738
00613647008737006136470087376136470087370613647008737
1061364700873410613647008734

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used 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), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)517-2425regulatory.affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
Device count
50
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
20613647028340Fisherbrand11002204110022042025-06-30
20613647028678Fisherbrand13-711-274MD13711274MD2025-06-30
20613647028685Fisherbrand13-711-336MD13711336MD2025-06-30
30613647028699Fisherbrand13-711-5AMMD137115AMMD2025-06-30
30613647028712Fisherbrand13-711-9AMMD137119AMMD2025-06-30
00613647029855Fisherbrand121011F2141270512025-06-30
00613647029862Fisherbrand120953F141275542025-06-30
20613647010901FisherbrandSC-150-100135001002025-04-30
20613647010918FisherbrandSC-180-100135001012025-04-30
20613647010925FisherbrandSC-220-100135001022025-04-30
20613647010932FisherbrandSC-250-100135001032025-04-30
20613647018846Fisherbrand23101000231010002025-04-30
20613647018853Fisherbrand23101001231010012025-04-30
20613647018860Fisherbrand23101002231010022025-04-30
20613647018877Fisherbrand23101003231010032025-04-30
20613647018884Fisherbrand23101004231010042025-04-30
20613647018891Fisherbrand23101005231010052025-04-30
20613647024847Fisherbrand19-041-372B19041372B2025-04-30
30613647024851Fisherbrand19-041-372C19041372C2025-04-30
20613647024861Fisherbrand19-041-372D19041372D2025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810164510822Atida Viral Transport Medium (Non-inactivated Type)ACESO LABORATORIES INC.JSM2026-03-23
06975025179250BabioJinan Babio Biotechnology Co., Ltd.JSM2026-01-27
06975025179267BabioJinan Babio Biotechnology Co., Ltd.JSM2026-01-27
06975025179274BabioJinan Babio Biotechnology Co., Ltd.JSM2026-01-27
06975025179281BabioJinan Babio Biotechnology Co., Ltd.JSM2026-01-27
06975025179298BabioJinan Babio Biotechnology Co., Ltd.JSM2026-01-27
06975025179304BabioJinan Babio Biotechnology Co., Ltd.JSM2026-01-27
58053326011820BD FCTCOPAN ITALIA SPAJSM2026-01-26
00848838066856Liquid Amies,Dual Swab PK/50REMEL, INC.JSM2025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500REMEL, INC.JSM2025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50REMEL, INC.JSM2025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500REMEL, INC.JSM2025-06-18
00848838066917Liquid Stuarts,Dual Swab PK/50REMEL, INC.JSM2025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100REMEL, INC.JSM2025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50REMEL, INC.JSM2025-06-18
58053326009551Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
18053326009867Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
18053326010283Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
08053326010446Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
58053326011073Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
58053326011189Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
18053326010405Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
58053326011714UriSponge™COPAN ITALIA SPAJSM2025-03-12
00840165400273Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCJSM2025-02-21
00840165400297Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCJSM2025-02-21
00840165400471Starswab Multitrans SystemPretium Canada Packaging ULCJSM2025-02-21
00840165400495Starswab Multitrans SystemPretium Canada Packaging ULCJSM2025-02-21
00840165400518Starswab Multitrans SystemPretium Canada Packaging ULCJSM2025-02-21
00840165400532Starswab Multitrans SystemPretium Canada Packaging ULCJSM2025-02-21
00840165400556Starswab Multitrans SystemPretium Canada Packaging ULCJSM2025-02-21