Catalog Number
-
Brand Name
V.A.C.®
Version/Model Number
M6275069/5 M6275069/10
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
Yes
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
-
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
9f8d4fa4-7ce1-404b-8727-3c45c3f81237
Public Version Date
September 09, 2020
Public Version Number
4
DI Record Publish Date
November 22, 2017
Package DI Number
00878237001295
Quantity per Package
10
Contains DI Package
00878237001257
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10 Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 63 |