| Primary Device ID | 00040565125961 |
| NIH Device Record Key | cd3562cc-ac09-4274-95cc-63af6522ad72 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REN/ASYS ADHESIVE GEL PATCH |
| Version Model Number | 66801082 |
| Catalog Number | 66801082 |
| Company DUNS | 216344051 |
| Company Name | SMITH & NEPHEW MEDICAL LIMITED |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00040565125954 [Primary] |
| GS1 | 00040565125961 [Package] Contains: 00040565125954 Package: Carton [10 Units] In Commercial Distribution |
| GS1 | 30040565125962 [Package] Package: Case [5 Units] In Commercial Distribution |
| NAD | Dressing, Wound, Occlusive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-07 |
| Device Publish Date | 2020-10-02 |
| 05000223402464 - IV3000 6X8CM-CARTON OF 100 | 2023-09-07 Moisture responsive IV catheter dressing |
| 05000223049249 - IV3000 6X8.5CM-CARTON OF 10 | 2023-09-07 Moisture responsive IV catheter dressing |
| 05000223049256 - IV3000 | 2023-09-07 Moisture responsive catheter dressing. 10cm x 14cm Ctn of 10 |
| 05000223463113 - OPSITE POST-OP VISIBLE 20X10CM CTN 20 | 2023-09-07 Waterproof, bacteria proof dressing with absorbent see through pad |
| 00040565122564 - IODOSORB | 2023-09-07 Cadexomer iodine gel. 10g. Ctn of 1 Tube |
| 05000223500184 - RENASYS | 2023-09-07 Renasys XL Transparent Film Dressing |
| 05000223500207 - RENASYS | 2023-09-07 Renasys-F XL Foam Dressing Kit With Soft Port |
| 30040565118254 - IV3000 | 2023-09-07 4” x 5” Non-Sterile Bulk |