Duns Number:730624095
Device Description: The V-Vac Suction Unit is a manual portable unit designed to provide quick and effective s
Catalog Number
985000
Brand Name
V-Vac starter kit
Version/Model Number
985000
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
K862875
Product Code
BTA
Product Code Name
Pump, Portable, Aspiration (Manual Or Powered)
Public Device Record Key
c26f017d-bf20-4099-8e45-053d0f742cf0
Public Version Date
August 23, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 80 |