| Primary Device ID | 00815696021037 |
| NIH Device Record Key | 89a1184f-a034-4f1d-9ead-8dd27ae0b197 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | George King Congential Factor Deficiency Convenience Kit |
| Version Model Number | 0055-5 |
| Company DUNS | 066761271 |
| Company Name | GEORGE KING BIO-MEDICAL, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *-70˚C or below |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815696021037 [Primary] |
| GJT | Plasma, Coagulation Factor Deficient |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-03-20 |
| 00815696021341 - George King SysCOR-40 Control Kit | 2023-03-23 SysCOR-40 Control Kit is a system control convenience kit containing 20 normal and 20 abnormal plasma controls to assist with in |
| 00815696021297 - George King Pooled Normal Plasma | 2022-03-11 George King Pooled Normal Plasma is fresh frozen citrated human plasma is intended to be used as a normal control for the one-st |
| 00815696021303 - George King Single Donor Normal Plasma | 2022-03-11 George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for |
| 00815696021310 - George King Factor VIII Deficient Plasma | 2022-03-11 George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII Deficient don |
| 00815696021280 - George King Coumadin® Plasma | 2022-01-28 George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is |
| 00815696021266 - George King von Willebrand Plasma, Type 2B | 2021-04-05 George King von Willebrand plasma, Type 2B, is a citrated human fresh frozen plasma derived from a donor diagnosed with vWD Type |
| 00815696021259 - George King Pooled Normal Plasma | 2021-01-18 George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the on |
| 00815696021228 - George King Single Donor Normal Plasma | 2020-07-06 George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for |