| Primary Device ID | 00849405011200 |
| NIH Device Record Key | 96d3fd5d-d3a3-4f0e-a0cd-471d480b44c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Genadyne XLR8 Wound Vacuum System |
| Version Model Number | A4-S0002 |
| Company DUNS | 006616130 |
| Company Name | GENADYNE BIOTECHNOLOGIES INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849405011200 [Primary] |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 10849405002793 - Hybrid Dressing - Revo Unsterile | 2026-03-24 |
| 10849405002809 - Hybrid Dressing - Revo Unsterile | 2026-03-24 |
| 10849405002816 - Hybrid Dressing - Revo Unsterile | 2026-03-24 |
| 10849405002823 - Hybrid Dressing - Revo Unsterile | 2026-03-24 |
| 10849405002830 - Hybrid Dressing - Revo Unsterile | 2026-03-24 |
| 10849405002847 - Hybrid Dressing - Revo Unsterile | 2026-03-24 |
| 00849405002581 - Genadyne DUO NPWT | 2026-03-17 The Genadyne DUO is a type of negative pressure wound therapy where its intended use is for patients who would benefit from a su |
| 00849405024101 - XLR8 Abdominal Wound Dressing Kit | 2026-03-17 XLR8 Abdominal wound dressing kit is indicated for use in conjuction with Genadyne NPWT System for patients who have open abdomi |