FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647028623
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
11002232
Catalog number
11002232
Device description
PROTOCOL SACCOMANNO FLUID 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
LEAPRESERVATIVE, CYTOLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEAPreservative, CytologicalPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647028623PackageGS11In Commercial Distribution
00613647028629PrimaryGS10
10613647028626Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702862320613647028623
00613647028629006136470286296136470286290613647028629
1061364702862610613647028626

GMDN Terms#

Term, Definition table
TermDefinition
Saccamanno solution IVDA solution typically containing 50% ethanol and 2% polyethylene glycol (carbowax) diluted in water, intended to be used as a fixative particularly for liquid cytologic specimens such as sputum, urine, bronchial washings, and pleural and peritoneal fluids. Saccomanno solution causes lysis of red blood cells and renders uncoagulated proteins and mucus soluble for centrifugation and filtration.

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
10849832027819Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2026-05-22
09551020410030PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410047PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410108PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410115PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410146PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410221PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410238PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410245PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410252PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410283PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410436PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410443PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410450PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410467PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410474PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410481PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410498PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
00613647028629FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEA2025-04-30
10849832002946Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2024-12-27
00849832002949Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2024-12-27
00810160180357SUPMEDICSupmedics Inc.LEA2024-11-04
00673693483032EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-10-22
00673693105279EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693105286EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693230858EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693230865EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693344692EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693344708EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693088985EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-02