FDA UDI
In Commercial Distribution
🇺🇸 United States
Kit SST-A 10 for PF96
DI: B765PRD7150300
·
Model: 01
·
BIOLOG-ID
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Kit SST-A 10 for PF96
- Primary DI
- B765PRD7150300
- Version / Model
- 01
- Company Name
- BIOLOG-ID
- Labeler DUNS
- 277828187
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-11
- Public Version
- 2
- Public Version Date
- 2020-04-29
- Public Version Status
- Update
- Public Device Record Key
- c8634f4e-6c62-427e-bd97-42dd184537b9
Device Description
Kit SST-A for the retrofitting of the Helmer PF96 incubator
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
- Yes
- 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 |
|---|---|---|---|---|
| KSE | Refrigerator, Freezer, Blood Storage | Hematology | 864.9700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63461 | Blood refrigerator/incubator | An electrically-powered device intended to be used to store and/or transport whole blood and blood components (e.g., blood cells, plasma) while keeping them cold (from 1° to 6° Celsius), or alternatively warm (from 20° to 24° Celsius). It may include an active system to regulate the temperature (e.g., compressor), handles and/or wheels for transportation, and alarms which signal unintentional changes in temperature and power failures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B765PRD7150300 | HIBCC |