| Primary Device ID | 00815696020511 |
| NIH Device Record Key | e687655e-be51-4344-ab47-e4236b0f38b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | George King CORE Kit |
| Version Model Number | 0070-50 |
| 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 |
| 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 | 00815696020511 [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 | 2018-06-25 |
| Device Publish Date | 2018-05-23 |
| 00815696020511 | George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated human plasma derived |
| 00815696020504 | George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated human plasma derived |