FDA.reportPublic FDA data

Hobbs Medical Saccomanno Cell Transport System

Primary DI
M84941012
Brand
Hobbs Medical Saccomanno Cell Transport System
Company
HOBBS MEDICAL, INC.
Model
4101
Catalog number
4101
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LDZFixative, Alcohol Containing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDZFixative, Alcohol ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M84941012PackageHIBCC10In Commercial Distribution
M84941010PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
076769355
Device count
1
DM exempt
false
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
M84921890CleanCapture Aspiration Catheter218921892026-01-14
M84921891CleanCapture Aspiration Catheter218921892026-01-14
M84960050Hobbs Biliary Amsterdam Stent Kit600560052016-09-21
M84960060Hobbs Biliary Amsterdam Stent Kit600660062016-09-21
M84960090Hobbs Biliary Amsterdam Stent Kit600960092016-09-21
M84960110Hobbs Biliary Amsterdam Stent Kit601160112016-09-21
M84960120Hobbs Biliary Amsterdam Stent Kit601260122016-09-21
M84960130Hobbs Biliary Amsterdam Stent Kit601360132016-09-21
M84960140Hobbs Biliary Amsterdam Stent Kit601460142016-09-21
M84960150Hobbs Biliary Amsterdam Stent Kit601560152016-09-21
M84963100Freeman Pancreatic Flexi-Stent Kit631063102016-09-21
M84963110Freeman Pancreatic Flexi-Stent Kit631163112016-09-21
M84963200Freeman Pancreatic Flexi-Stent Kit632063202016-09-21
M84963210Freeman Pancreatic Flexi-Stent Kit632163212016-09-21
M84965010Freeman Pancreatic Flexi-Stent Kit650165012016-09-21
M84965020Freeman Pancreatic Flexi-Stent Kit650265022016-09-21
M84965030Freeman Pancreatic Flexi-Stent Kit650365032016-09-21
M84965040Freeman Pancreatic Flexi-Stent Kit650465042016-09-21
M84965050Freeman Pancreatic Flexi-Stent Kit650565052016-09-21
M84965060Freeman Pancreatic Flexi-Stent Kit650665062016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693181723EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-11-19
00673693228299EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-09-04
00673693085465EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00673693556729EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00673693755146EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00860011780571Chemical Service Labs, LLCProtean Resources, LLC.LDZ2024-03-18
00860011780588Chemical Service Labs, LLCProtean Resources, LLC.LDZ2024-03-18
00380740129590AlinityAbbott GmbHLDZ2023-11-16
M84941010Hobbs Medical Saccomanno Cell Transport SystemHOBBS MEDICAL, INC.LDZ2023-06-12
00810047420545N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420552N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420569N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420934N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420941N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420958N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420965N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00816085021393Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021409Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021478Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022376Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022444Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022468Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022499Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022512Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085020181Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021423Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021430Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021447Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021454Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021461Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11