Duns Number:102726734
Device Description: 500 ml Canister (with Gel) for Infovac and VAC Ulta Therapy Systems
Catalog Number
-
Brand Name
INFOV.A.C.™
Version/Model Number
M8275063/5 M8275063/10
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
K063740,K063740,K063740
Product Code
OMP
Product Code Name
Negative Pressure Wound Therapy Powered Suction Pump
Public Device Record Key
dfd5248c-23fd-45ba-a582-4662c73577d7
Public Version Date
September 09, 2020
Public Version Number
5
DI Record Publish Date
September 05, 2016
Package DI Number
00849554002012
Quantity per Package
5
Contains DI Package
00849554002074
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
5 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 |