Duns Number:119193803
Device Description: Using simple principles of fluid mechanics, multi-walled WhisperSafe HVE Tips reduce air t Using simple principles of fluid mechanics, multi-walled WhisperSafe HVE Tips reduce air turbulence—and the resulting noise. They are so quiet, you will wonder if your suction is working! Their honeycomb cross-sectional design also creates superior stiffness for the ultimate in retraction, and doubles as a screen to eliminate aspiration of soft tissue and foreign objects. Tips fit all standard HVE valves. 6" long. Non-vented
Catalog Number
71-19710
Brand Name
WhisperSafe HVE Tips
Version/Model Number
7119710
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EHZ
Product Code Name
Evacuator, Oral Cavity
Public Device Record Key
8359d7af-4623-45f7-a414-252a413307c0
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 19, 2018
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |