V.A.C.RX4
GUDID 00849554004740
V.A.C.RX4 Therapy System
KCI USA, INC.
Negative-pressure wound therapy system pump, electric| Primary Device ID | 00849554004740 |
| NIH Device Record Key | 746cc05a-d287-4998-aef9-6dbb6245484b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | V.A.C.RX4 |
| Version Model Number | RX4DEV01/US |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849554004740 [Direct Marking] |
| GS1 | 00849554004764 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160487
FDA Product Code
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-08-01 |
| Device Publish Date | 2017-05-09 |
Devices Manufactured by KCI USA, INC.
| 00849554008632 - 3M™ Snap™ | 2024-10-03 3M™ Snap™ Therapy Strap, STPAM, Medium, 1 Each/Case |
| 00849554008618 - 3M™ Snap™ | 2024-08-19 3M™ Snap™ Therapy Strap, STPAS, Small, 1 Each/Case |
| 00849554008656 - 3M™ Snap™ | 2024-08-19 3M™ Snap™ Therapy Strap, STPAL, Large, 1 Each/Case |
| 00849554008670 - 3M™ Snap™ | 2024-08-19 3M™ Snap™ Plus Therapy Strap, STPASP, Small, 1 Each/Case |
| 00849554008694 - 3M™ Snap™ | 2024-08-19 3M™ Snap™ Plus Therapy Strap, STPAMP, Medium, 1 Each/Case |
| 00849554008717 - 3M™ Snap™ | 2024-08-19 3M™ Snap™ Plus Therapy Strap, STPALP, Large, 1 Each/Case |
| 00849554011762 - 3M™ V.A.C.® | 2024-08-19 ACTIV.A.C., CANISTER WITH GEL 10/CASE, ATHLONE, IH1078249, BSI MDR, 3M REBRANDING |
| 00849554015401 - ActiV.A.C.™ | 2024-08-08 ACTIV.A.C. CANISTER WITH GEL 10/CASE, ATHLONE, IH1078249, None, 3M REBRANDING, NON STERILE |
Trademark Results [V.A.C.RX4]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 V.A.C.RX4 86256609 5271511 Live/Registered |
KCI LICENSING, INC. 2014-04-18 |
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