| Primary Device ID | 00040565126944 |
| NIH Device Record Key | 5ad54023-db74-47b9-9113-3eb54102f56d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RENASYS GO v2 HOME |
| Version Model Number | 66801496 |
| Catalog Number | 66801496 |
| Company DUNS | 216344051 |
| Company Name | SMITH & NEPHEW MEDICAL LIMITED |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00040565126944 [Primary] |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-25 |
| Device Publish Date | 2020-05-15 |
| 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 |