FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisherbrand
DI: 00613647028629
·
Model: 11002232
·
FISHER SCIENTIFIC COMPANY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Fisherbrand
- Primary DI
- 00613647028629
- Version / Model
- 11002232
- Catalog Number
- 11002232
- Company Name
- FISHER SCIENTIFIC COMPANY L.L.C.
- Labeler DUNS
- 004321519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2025-04-30
- Public Version
- 1
- Public Version Date
- 2025-05-08
- Public Version Status
- New
- Public Device Record Key
- 35e6caad-f731-4b8e-a1ee-14ecca7007de
Device Description
PROTOCOL SACCOMANNO FLUID 1GAL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LEA | PRESERVATIVE, CYTOLOGICAL | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57752 | Saccamanno solution IVD | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20613647028623 | GS1 | CASE | 1 | In Commercial Distribution | |
| Primary | 00613647028629 | GS1 | ||||
| Unit of Use | 10613647028626 | GS1 |
Customer Contacts
- Phone
- +1(724)517-1500
- [email protected]