| Primary Device ID | 00849405022138 |
| NIH Device Record Key | ae70320e-e0fa-4048-83ea-60ebb60c7279 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AG Foam Kit Large |
| Version Model Number | AG-LFOAM2 |
| Catalog Number | AG-LFOAM2 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849405022138 [Primary] |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-29 |
| Device Publish Date | 2025-01-21 |
| 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 |