Duns Number:627879687
Device Description: The disposable BioVac direct suction device is indicated for transendoscopic evacuation, d The disposable BioVac direct suction device is indicated for transendoscopic evacuation, debulking, and/or lysing of blood, retained blood clots, or fluid, such as residual stool, within the gastrointestinal tract through the biopsy/suction channel of flexible gastrointestinal endoscopes. It also provides access for endoscopic device passage and exchange, and allows for supplemental intraprocedural irrigation when desired.
Catalog Number
00711512
Brand Name
BioVac
Version/Model Number
00711512
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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"
Yes
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
KQT
Product Code Name
EVACUATOR, GASTRO-UROLOGY
Public Device Record Key
4d77f7d1-2520-495d-a670-6a0c7f100c26
Public Version Date
March 31, 2020
Public Version Number
5
DI Record Publish Date
September 17, 2016
Package DI Number
10816765011567
Quantity per Package
5
Contains DI Package
00816765011560
Package Discontinue Date
March 31, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |