Duns Number:730624095
Device Description: The V-Vac Suction Unit is a manual portable unit designed to provide quick and effective s The V-Vac Suction Unit is a manual portable unit designed to provide quick and effective suction. Fully assembled, it weighs less than one pound (0,45 kg) and can be adjusted to accomodate different hand sizes or to provide a range of suction pressures from no more than ~170mmHg up to ~380mmHg.
Catalog Number
98500020
Brand Name
V-Vac Starter kit w/out Catheter
Version/Model Number
98500020
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
d7db25c9-87ce-4a72-93a5-b15884fb6d31
Public Version Date
April 26, 2021
Public Version Number
1
DI Record Publish Date
April 16, 2021
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 |