FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647028609
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
11002230
Catalog number
11002230
Device description
BOUINS FLUID FIXATIVE 1GAL
Published
2025-04-30
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
IGNFLUID, BOUIN'S

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IGNFluid, Bouin'SPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647028609PackageGS11In Commercial Distribution
00613647028605PrimaryGS10
10613647028602Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702860920613647028609
00613647028605006136470286056136470286050613647028605
1061364702860210613647028602

GMDN Terms#

Term, Definition table
TermDefinition
Histology tissue processing reagent kit IVDA collection of reagents intended to be used for tissue processing in a histology laboratory to prepare biological tissues or clinical tissue specimens for embedding, or related procedures, by successively removing water and alcohol. It may consist of a fixative (e.g., formalin), a dehydrating agent (e.g., alcohol) and a clearing reagent (e.g., xylene).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)517-1500regulatory.affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
Device count
4
DM exempt
true
Premarket exempt
true
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
00613647028346Fisherbrand11002204110022042025-06-30
00613647028674Fisherbrand13-711-274MD13711274MD2025-06-30
00613647028681Fisherbrand13-711-336MD13711336MD2025-06-30
00613647028698Fisherbrand13-711-5AMMD137115AMMD2025-06-30
00613647028711Fisherbrand13-711-9AMMD137119AMMD2025-06-30
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
00613647010907FisherbrandSC-150-100135001002025-04-30
00613647010914FisherbrandSC-180-100135001012025-04-30
00613647010921FisherbrandSC-220-100135001022025-04-30
00613647010938FisherbrandSC-250-100135001032025-04-30
00613647018842Fisherbrand23101000231010002025-04-30
00613647018859Fisherbrand23101001231010012025-04-30
00613647018866Fisherbrand23101002231010022025-04-30
00613647018873Fisherbrand23101003231010032025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613647028605FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IGN2025-04-30
00673693080040EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIGN2024-07-25
00673693171168EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIGN2024-07-25
00613647022986FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IGN2022-12-07
20613647022980FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IGN2022-12-07
SO1030852042008Rowley Biochemical Jax BouinsTRANSENE COMPANY, INC.IGN2019-09-13
SO306852042008Rowley Biochemical Bouin's FluidTRANSENE COMPANY, INC.IGN2019-09-13
SO936852042008Rowley Biochemical Alcoholic Bouin's FluidTRANSENE COMPANY, INC.IGN2019-09-13