| Primary Device ID | 08806129660246 |
| NIH Device Record Key | 07807b89-28cd-4e62-8e3a-469d31b6bda8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medifoam H band large |
| Version Model Number | MB352003L |
| Company DUNS | 987669599 |
| Company Name | Genewel Co.,Ltd. |
| Device Count | 9 |
| 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 | 08806129660246 [Unit of Use] |
| GS1 | 08806129660253 [Primary] |
| GS1 | 08806129660260 [Primary] |
| NAC | Dressing, Wound, Hydrophilic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-11 |
| Device Publish Date | 2025-03-03 |
| 08806129660178 - Medifoam | 2025-03-11 |
| 08806129660192 - Medifoam band | 2025-03-11 |
| 08806129660215 - Medifoam H band Medium | 2025-03-11 |
| 08806129660246 - Medifoam H band large | 2025-03-11 |
| 08806129660246 - Medifoam H band large | 2025-03-11 |
| 08806129660048 - Medifoam H | 2022-11-07 |
| 08806129660093 - Medifoam | 2022-11-07 Medifoam is indicated for the management of exuding wounds such as ulcers, burns, surgical/traumatic/acute, lacerations, abrasio |
| 08806129660055 - Medifoam H beauty | 2022-11-07 Medifoam H beauty is intended to manage and assist in wound healing by absorbing exudate in wounds for minimal wound maceration, |
| 08806129660062 - Medifoam H band | 2022-11-07 |