FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647003071
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
GD14375180
Catalog number
22363149
Device description
FB COMMODE SPECIMN COL 100/CS
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
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNICONTAINER, SPECIMEN, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647003071PackageGS11In Commercial Distribution
00613647003077PrimaryGS10
10613647003074Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364700307120613647003071
00613647003077006136470030776136470030770613647003077
1061364700307410613647003074

GMDN Terms#

Term, Definition table
TermDefinition
Rectal/faecal specimen collection kitA collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a rectal/faecal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, spatula], and a covered receptacle with or without an additive/medium (e.g., cell or nucleic acid preservation solution, Carey-Blair transport medium). 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
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00810180842211LabChoice Sputum Containers, 40 mL Dynarex CorporationNNI2025-06-16
00840117337367LabChoice Pet Cell Bottle, 250 mL Dynarex CorporationNNI2025-06-16
00840117337374LabChoice Pet Cell Bottle, 500 mL Dynarex CorporationNNI2025-06-16
00840117337381LabChoice Pet Cell Bottle, 1000 mL Dynarex CorporationNNI2025-06-16
00840165500218HistoplexStarplex Scientific Corp.NNI2025-05-30
00840165500096StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
00840165500119LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500133LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500157LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500171LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500195HistoplexStarplex Scientific Corp.NNI2025-05-28
00840165500416LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165500430LeakbusterStarplex Scientific Corp.NNI2025-05-28
00840165401195LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00840165401416LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00840117336414LabChoice 24-Hour Urine Collection Container, 3000 mL Dynarex CorporationNNI2025-04-17
10827989003214Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-04-15
00810180841689LabChoice Specimen Bags, Clear, 8" x 10", 1.8 MILDynarex CorporationNNI2025-04-07
00810180841672LabChoice Specimen Bags with Pouch, 4" x 6", 1.8 MIL Dynarex CorporationNNI2025-04-07
29120126131459VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00810180841665LabChoice Specimen Bags, 6" x 9", 1.8 MIL, Non-SterileDynarex CorporationNNI2025-03-28
00810180841658LabChoice Specimen Bags, 12" x 15", 1.8 milDynarex CorporationNNI2025-03-28
10827989003221Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-03-13
00810180841467LabChoice Specimen Containers, 60 mL, Non-SterileDynarex CorporationNNI2025-03-11
00810180841474LabChoice Specimen Containers, 100 mL, NonSterileDynarex CorporationNNI2025-03-11
00810180841450LabChoice Specimen Containers, 40 mL, Non-SterileDynarex CorporationNNI2025-03-11
00860009784895Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06
00840165400976Starplex Pretium Canada Packaging ULCNNI2025-03-04
00850025860017ESD Specimen TrayMicro-tech UsaNNI2025-02-28
04250306301219SalivaGene CollectorInvitek Molecular GmbHNNI2025-02-12