FDA UDI
In Commercial Distribution
🇺🇸 United States
George King Congential Factor Deficiency Convenience Kit
DI: 00815696021037
·
Model: 0055-5
·
GEORGE KING BIO-MEDICAL, INC
Product Codes
1
GMDN Terms
5
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- George King Congential Factor Deficiency Convenience Kit
- Primary DI
- 00815696021037
- Version / Model
- 0055-5
- 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
- 2017-03-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 89a1184f-a034-4f1d-9ead-8dd27ae0b197
Device Description
George King CFD is a Congenital Factor Deficient Convenience Kit which contains five different factor deficient plasma's for product evaluation
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | Hematology | 864.7290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56047 | Coagulation factor XII 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 quantitative measurement of coagulation factor XII in a clinical specimen. | No | Active |
| 56042 | Coagulation factor XI 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 quantitative measurement of coagulation factor XI in a clinical specimen. | No | Active |
| 56037 | Coagulation factor X 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 quantitative measurement of coagulation factor X in a clinical specimen. | No | Active |
| 56250 | Coagulation factor IX 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 quantitative measurement of coagulation factor IX in a clinical specimen. | No | Active |
| 56247 | Coagulation factor VII 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 quantitative measurement of coagulation factor VII in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815696021037 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- -70˚C or below