| Primary Device ID | 50849554007852 |
| NIH Device Record Key | 360f6ec1-5531-4df5-8b3c-a6ab0b1b661e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PREVENA RESTOR ROTO•FORM™ |
| Version Model Number | PRE5601 |
| Catalog Number | PRE5601 |
| Company DUNS | 102726734 |
| Company Name | KCI USA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849554007857 [Primary] |
| GS1 | 50849554007852 [Package] Contains: 00849554007857 Package: [1 Units] In Commercial Distribution |
| 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 | 2021-03-03 |
| Device Publish Date | 2021-02-23 |
| 50849554007852 | PREVENA RESTOR ROTO•FORM™ DRESSING-29CM X 31CM SYSTEM KIT |
| 00849554007864 | PREVENA RESTOR ROTO•FORM™ DRESSING-29CM X 31CM |