FDA UDI
In Commercial Distribution
🇺🇸 United States
StatFax
DI: 00850229007072
·
Model: 2600
·
AWARENESS TECHNOLOGY, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- StatFax
- Primary DI
- 00850229007072
- Version / Model
- 2600
- Company Name
- AWARENESS TECHNOLOGY, INCORPORATED
- Labeler DUNS
- 071065130
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-05
- Public Version
- 1
- Public Version Date
- 2023-06-13
- Public Version Status
- New
- Public Device Record Key
- 16826501-fd25-467c-a9e4-82aaefef6e53
Device Description
Digital Dry Bath
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 |
|---|---|---|---|---|
| JTQ | Bath, Incubators/Water, All | Microbiology | 866.2540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17489 | Microplate washer IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for washing microplates containing multiple individual sample wells (i.e., the removal of biological specimen residue, stains, or impurities) by dispensing and aspirating measured volumes of washing solution as part of the processing required to perform an in vitro diagnostic assay. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850229007072 | GS1 |