| Primary Device ID | 00851587006066 | 
| NIH Device Record Key | f746e5fe-829e-4119-b9b0-98ce3ef74c47 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | XSTAT | 
| Version Model Number | XSTAT-30 Gen 2 | 
| Catalog Number | FIN-0017-01 | 
| Company DUNS | 961523441 | 
| Company Name | REVMEDX, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| 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 | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 503-218-2172 | 
| info@revmedx.com | |
| Phone | 503-218-2172 | 
| info@revmedx.com | |
| Phone | 503-218-2172 | 
| info@revmedx.com | |
| Phone | 503-218-2172 | 
| info@revmedx.com | |
| Phone | 503-218-2172 | 
| info@revmedx.com | |
| Phone | 503-218-2172 | 
| info@revmedx.com | |
| Phone | 503-218-2172 | 
| info@revmedx.com | |
| Phone | 503-218-2172 | 
| info@revmedx.com | |
| Phone | 503-218-2172 | 
| info@revmedx.com | |
| Phone | 503-218-2172 | 
| info@revmedx.com | 
| Outer Diameter | 28.5 Millimeter | 
| Outer Diameter | 28.5 Millimeter | 
| Outer Diameter | 28.5 Millimeter | 
| Outer Diameter | 28.5 Millimeter | 
| Outer Diameter | 28.5 Millimeter | 
| Outer Diameter | 28.5 Millimeter | 
| Outer Diameter | 28.5 Millimeter | 
| Outer Diameter | 28.5 Millimeter | 
| Outer Diameter | 28.5 Millimeter | 
| Outer Diameter | 28.5 Millimeter | 
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00851587006066 [Primary] | 
| GS1 | 10851587006063 [Package] Package: flexible pouch [1 Units] In Commercial Distribution | 
| NAB | Gauze / Sponge,Nonresorbable For External Use | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-04-05 | 
| Device Publish Date | 2019-03-28 | 
| 10851587006056 | A hemostatic device for severe bleeding. Each device comprises approximately 92 small hemostatic | 
| 00851587006042 | A hemostatic device for severe bleeding. Each device comprises approximately 38 small hemostatic | 
| 00851587006066 | A hemostatic device for severe bleeding. Each device comprises approximately 108 small hemostati | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  XSTAT  85475849  4584835 Live/Registered | RevMedx, Inc. 2011-11-17 | 
|  XSTAT  73671262  1512407 Dead/Cancelled | WINSTANDLEY & ASSOCIATES, INC. 1987-07-09 | 
|  XSTAT  73517804  not registered Dead/Abandoned | MING TELECOMPUTING INC. 1985-01-16 |