FDA UDI
In Commercial Distribution
🇺🇸 United States
George King Pooled Normal Plasma
DI: 00815696020115
·
Model: 0010-0.5
·
GEORGE KING BIO-MEDICAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- George King Pooled Normal Plasma
- Primary DI
- 00815696020115
- Version / Model
- 0010-0.5
- Company Name
- GEORGE KING BIO-MEDICAL, INC
- Labeler DUNS
- 066761271
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b1871758-6194-46ec-9c3b-a69f3dfdf0bc
Device Description
George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GGN | Plasma, Coagulation Control | Hematology | 864.5425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30590 | Multiple coagulation factor IVD, control | A material which is used to verify the performance of an assay intended to be 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815696020115 | GS1 |
Customer Contacts
- Phone
- 1-800-255-5108
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- -70˚C or below