| Primary Device ID | 00815696020054 |
| NIH Device Record Key | ba9a9385-9765-43cb-8202-4e06db70b29c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | George King Factor VII Deficient Plasma |
| Version Model Number | 0700-1.0 |
| 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 | 00815696020054 [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 | 2016-08-23 |
| 00815696020924 | George King Factor VII Deficient Plasma is a fresh frozen citrated human plasma derived from con |
| 00815696020054 | George King Factor VII Deficient Plasma is fresh frozen citrated human plasma derived from conge |