FDA UDI
In Commercial Distribution
🇺🇸 United States
CRYOcheck™ Prekallikrein Deficient Plasma
DI: 00843876000381
·
Model: FDPK-10
·
Precision Biologic Inc
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- CRYOcheck™ Prekallikrein Deficient Plasma
- Primary DI
- 00843876000381
- Version / Model
- FDPK-10
- Company Name
- Precision Biologic Inc
- Labeler DUNS
- 244713368
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5d9bb86a-6c0b-4690-9d8d-1ba769ea190a
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
- No
- 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 |
|---|---|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | Hematology | 864.7290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30595 | Multiple coagulation factor IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen. | No | Active |
| 56073 | Coagulation factor prekallikrein/kallikrein IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qquantitative measurement of coagulation factor prekallikrein or kallikrein, also known as Fletcher factor, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843876000381 | GS1 | ||||
| Unit of Use | 00843876010380 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990296 | 000 |