Duns Number:216344051
Device Description: A powered suction pump with accessory Wound Dressing Kits designed for Negative Pressure W A powered suction pump with accessory Wound Dressing Kits designed for Negative Pressure Wound Therapy (NPWT).
Catalog Number
66801281
Brand Name
RENASYS TOUCH DEVICE & POWER SUP
Version/Model Number
66801281
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181204
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
5b70ec4d-77bd-4b6e-9725-d56f0b87ed24
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
October 15, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 126 |
| U | Unclassified | 1 |