| Primary Device ID | 00815696021211 |
| NIH Device Record Key | 9a00b31b-8ff2-41c6-b273-51be91ded3e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | George King Factor V Deficient Plasma |
| Version Model Number | 0500-200.0 |
| 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 | false |
| 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 |
| Phone | 1-800-255-5108 |
| plasma@kingbiomed.com |
| Special Storage Condition, Specify | Between 0 and 0 *Specifiy -70 degress C or below |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815696021211 [Primary] |
| GJT | Plasma, Coagulation Factor Deficient |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-06 |
| Device Publish Date | 2020-02-27 |
| 00815696020917 | George King Factor V Deficient Plasma is fresh frozen citrated human plasma derived from congeni |
| 00815696020023 | George King Factor V Deficient Plasma is fresh frozen citrated human plasma derived from congeni |
| 00815696021211 | George King Factor V Deficient Plasma is fresh frozen citrated human plasma derived from congeni |