Duns Number:216344051
Device Description: Clinician User Manual US Only
Catalog Number
66021739
Brand Name
RENASYS GO
Version/Model Number
66021739
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
K152163,K152163
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
47eea5d8-1905-4684-b525-ce2457f1cf51
Public Version Date
October 08, 2020
Public Version Number
4
DI Record Publish Date
December 01, 2016
Package DI Number
05000223491451
Quantity per Package
25
Contains DI Package
00040565127149
Package Discontinue Date
October 07, 2020
Package Status
Not 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 |