| Primary Device ID | 00815696020085 |
| NIH Device Record Key | 0d42ae2c-4c78-4f18-a015-c3ae3656e5e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | George King Factor XII Deficient Plasma |
| Version Model Number | 1200-1.0 |
| 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 | |
| Phone | 1-800-255-5108 |
| plasma@kingbiomed.com | |
| Phone | 1-800-255-5108 |
| plasma@kingbiomed.com |
| Special Storage Condition, Specify | Between 0 and 0 *-70˚C or below |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815696020085 [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 | 2016-08-22 |
| 00815696020269 | George King Factor XII Deficient Plasma is fresh frozen citrated human plasma derived from conge |
| 00815696020085 | George King Factor XII Deficient Plasma is fresh frozen citrated human plasma derived from conge |