| Primary Device ID | 00815696021228 |
| NIH Device Record Key | 00a69a68-088d-47f8-bd2b-a89f64124561 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | George King Single Donor Normal Plasma |
| Version Model Number | 0001-50.0 |
| 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 | |
| Phone | 1-800-255-5108 |
| plasma@kingbiomed.com | |
| Phone | 1-800-255-5108 |
| plasma@kingbiomed.com | |
| Phone | 1-800-255-5108 |
| plasma@kingbiomed.com | |
| Phone | 1-800-255-5108 |
| plasma@kingbiomed.com | |
| Phone | 1-800-255-5108 |
| plasma@kingbiomed.com | |
| Phone | 1-800-255-5108 |
| plasma@kingbiomed.com | |
| 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 degrees C or below |
| Special Storage Condition, Specify | Between 0 and 0 *-70 degrees C or below |
| Special Storage Condition, Specify | Between 0 and 0 *-70 degrees C or below |
| Special Storage Condition, Specify | Between 0 and 0 *-70 degrees C or below |
| Special Storage Condition, Specify | Between 0 and 0 *-70 degrees C or below |
| Special Storage Condition, Specify | Between 0 and 0 *-70 degrees C or below |
| Special Storage Condition, Specify | Between 0 and 0 *-70 degrees C or below |
| Special Storage Condition, Specify | Between 0 and 0 *-70 degrees C or below |
| Special Storage Condition, Specify | Between 0 and 0 *-70 degrees C or below |
| Special Storage Condition, Specify | Between 0 and 0 *-70 degrees C or below |
| Special Storage Condition, Specify | Between 0 and 0 *-70 degrees C or below |
| Special Storage Condition, Specify | Between 0 and 0 *-70 degrees C or below |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815696021228 [Primary] |
| GGN | Plasma, Coagulation Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-06 |
| Device Publish Date | 2020-06-26 |
| 00815696021105 | George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to |
| 00815696020603 | George King Single Donor Normal Plasma is fresh frozen human citrated plasma and is intended to |
| 00815696020559 | George King Single Donor Normal Plasma is fresh frozen citrared human plasma and is intended to |
| 00815696020160 | George King Single Donor Normal Plasma is fresh frozen human citrated plasma and is intended to |
| 00815696020153 | George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to |
| 00815696021228 | George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to |
| 00815696021303 | George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to |