FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearCell® FX1 Unit
DI: 08885016030003
·
Model: CBB-F011001-C
·
BIOLIDICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ClearCell® FX1 Unit
- Primary DI
- 08885016030003
- Version / Model
- CBB-F011001-C
- Company Name
- BIOLIDICS LIMITED
- Labeler DUNS
- 595253935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-24
- Public Version
- 1
- Public Version Date
- 2022-10-03
- Public Version Status
- New
- Public Device Record Key
- 2363c541-c1b4-4e4e-8aca-54a8741ae73c
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GKH | Apparatus, Automated Blood Cell Diluting | Hematology | 864.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35781 | Blood cell diluter | A mains electricity (AC-powered), automated or semi-automated device, typically used in the laboratory, to make appropriate dilutions of a blood sample for further analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08885016030003 | GS1 |