PREVENA PLUS™ CUSTOMIZABLE™
GUDID 00849554005303
Prevena Plus Customizable Dressing with Sensatrac Technology
KCI USA, INC.
Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, battery-powered, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use Negative-pressure wound therapy system, electric, single-use| Primary Device ID | 00849554005303 |
| NIH Device Record Key | 968556c6-242f-4c8e-92b6-f8a41ccc82c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PREVENA PLUS™ CUSTOMIZABLE™ |
| Version Model Number | Prevena Plus Customizable Dressing |
| Company DUNS | 102726734 |
| Company Name | KCI USA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849554005303 [Primary] |
| GS1 | 00849554005334 [Package] Package: 5 PACK [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153199
FDA Product Code
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by KCI USA, INC.
| 00849554014763 - 3M™ V.A.C. Veraflo Cleanse™ | 2024-04-26 3M™ V.A.C. Veraflo Cleanse™ Dressing, ULTVCL05MD, Medium, Cavilon Warning Label, 5/CS |
| 00849554014770 - 3M™ V.A.C. Veraflo™ | 2024-04-26 3M™ V.A.C. Veraflo™ Dressing, ULTVFL05SM, Small, Cavilon Warning Label, 5/CS |
| 00849554014787 - 3M™ V.A.C. Veraflo™ | 2024-04-26 3M™ V.A.C. Veraflo™ Dressing, ULTVFL05MD, Medium, Cavilon Warning Label, 5/CS |
| 00849554014794 - 3M™ V.A.C. Veraflo™ | 2024-04-26 3M™ V.A.C. Veraflo™ Dressing, ULTVFL05LG, Large, Cavilon Warning Label, 5/CS |
| 50849554013860 - 3M™ V.A.C.® | 2024-03-13 3M™ V.A.C.® Peel and Place Dressing Kit, EZ5SML, Small, 5/CS |
| 50849554015000 - 3M™ V.A.C.® | 2024-03-13 3M™ V.A.C.® Peel and Place Dressing Kit, EZ5MED, Medium, 5/CS |
| 50849554013884 - 3M™ V.A.C.® | 2024-03-13 3M™ V.A.C.® Peel and Place Dressing Kit, EZ5LRG, Large, 5/CS |
| 50849554014027 - 3M™ Veraflo™ | 2023-07-20 3M™ V.A.C. Veraflo Cleanse™ Dressing, ULTVCL05MD, Medium, Cavilon Warning Label, 5/CS |
Trademark Results [PREVENA PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREVENA PLUS 86758994 5087992 Live/Registered |
KCI LICENSING, INC. 2015-09-16 |
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