| Primary Device ID | 05000223465131 |
| NIH Device Record Key | 43ff7260-b7b1-4284-993a-576ee876639f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RENASYS GO |
| Version Model Number | 66800162 |
| Catalog Number | 66800162 |
| Company DUNS | 216344051 |
| Company Name | SMITH & NEPHEW MEDICAL LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 05000223465131 [Package] Contains: 05000223465186 Package: CASE [50 Units] In Commercial Distribution |
| GS1 | 05000223465186 [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 | 2016-12-08 |
| 05000223491000 | RENASYS GO Device US Only |
| 05000223465148 | RENASYS GO CARRY STRAP |
| 05000223465131 | RENASYS GO CARRY BAG |
| 00040565127392 | Home Healthcare User Manual US Only |
| 00040565127149 | Clinician User Manual US Only |
| 00040565125572 | RENASYS GO QRG USA Only |
| 30040565125306 | RENASYS GO Odor Filter |
| 30040565126952 | RENASYS GO Class II Power Supply |
| 30040565127331 | RENASYS GO 750ml Canister with Solidifier |
| 30040565127324 | RENASYS GO 300ml Canister with Solidifier |
| 30040565125290 | RENASYS GO O-Ring |