Duns Number:216344051
Device Description: RENASYS TOUCH CARRY STRAP
Catalog Number
66801276
Brand Name
RENASYS TOUCH
Version/Model Number
66801276
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K153209,K153209
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
2baf52b9-28d2-4d9f-83a2-414120dac6a6
Public Version Date
August 09, 2019
Public Version Number
4
DI Record Publish Date
November 02, 2016
Package DI Number
30040565126556
Quantity per Package
40
Contains DI Package
00040565126555
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
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 |