Duns Number:545287658
Device Description: 880VS series medical suction kit (aka suction kit) is a continuous suction kit powered fro 880VS series medical suction kit (aka suction kit) is a continuous suction kit powered from pressure gas. This is a long term, non-invasive, active medical device. It can be used to medical suction for tracheal suction, pharyngeal aspiration, gastro-intestinal drainage, and surgical suction.
Catalog Number
-
Brand Name
GENTEC®
Version/Model Number
880VS-760-CH/A-T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 11, 2042
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDP
Product Code Name
Regulator, Vacuum
Public Device Record Key
eb94e5d4-f85d-4bc6-9a61-f360bdd2dd41
Public Version Date
March 21, 2022
Public Version Number
1
DI Record Publish Date
March 11, 2022
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 | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |