| Primary Device ID | 00815696020146 |
| NIH Device Record Key | 2db27c4e-a9c8-4b06-b451-84e8c2541dbb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | George King Coumadin® Plasma |
| Version Model Number | 4000 - 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815696020146 [Primary] |
| GGN | Plasma, Coagulation Control |
| 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 | 2016-08-19 |
| 00815696020429 | George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz |
| 00815696020146 | George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz |
| 00815696021136 | George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz |
| 00815696021129 | George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz |
| 00815696021280 | George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz |