Duns Number:545287658
Device Description: 881VR series suction regulator is a dual purpose suction regulator with continuous suction 881VR series suction regulator is a dual purpose suction regulator with continuous suctioning mode and intermittent suctioning mode. It can be used to medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning (continuous) or gastrointestinal suction (intermittent)
Catalog Number
-
Brand Name
GENTEC®
Version/Model Number
881VR-300-00-T
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"
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
a4ce6997-e7c9-4c7f-8c3f-45b002e11f8e
Public Version Date
May 13, 2020
Public Version Number
3
DI Record Publish Date
May 26, 2017
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 |