| Primary Device ID | 00851587006097 |
| NIH Device Record Key | 25265485-0526-4a1b-97e9-1431b98cf309 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AirWrap XL |
| Version Model Number | FIN-0005-02 |
| Company DUNS | 961523441 |
| Company Name | Revmedx, 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851587006097 [Primary] |
| MHW | Dressing, Compression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-05 |
| Device Publish Date | 2026-02-25 |
| 00851587006073 - XGAUZE Trauma Pad | 2026-03-05 XGAUZE Trauma Pad Sterile Wound Dressing |
| 00851587006097 - AirWrap XL | 2026-03-05AirWrap XL |
| 00851587006097 - AirWrap XL | 2026-03-05 AirWrap XL |
| 00851587006080 - AirWrap | 2026-02-27 Pressure bandage |
| 00851587006226 - XSTAT P30 | 2026-02-27 Hemostatic device for severe bleeding. Each device comprises 3 pouches containing minisponges. Each pouch contains a radiopaqu |
| 00851587006066 - XSTAT | 2019-04-05 A hemostatic device for severe bleeding. Each device comprises approximately 108 small hemostatic sponges individually marked wi |
| 00851587006042 - XSTAT | 2018-07-06 A hemostatic device for severe bleeding. Each device comprises approximately 38 small hemostatic sponges individually marked wit |
| 10851587006056 - XSTAT | 2018-07-06 A hemostatic device for severe bleeding. Each device comprises approximately 92 small hemostatic sponges individually marked wit |