FDA.report

Fisherbrand

Primary DI
30613647008745
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
1490722
Catalog number
1490722
Device description
SWAB LIQ STUARTS WR 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

Related Records

Contact Domains

Product Codes

CodeName
JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT

Product Code Classifications

CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20613647008748PackageGS11In Commercial Distribution
30613647008745PackageGS12In Commercial Distribution
00613647008744PrimaryGS10
10613647008741Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364700874820613647008748
3061364700874530613647008745
00613647008744006136470087446136470087440613647008744
1061364700874110613647008741

GMDN Terms

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

Contacts

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

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30613647028712Fisherbrand13-711-9AMMD137119AMMD2025-06-30
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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

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