Duns Number:119193803
Device Description: Replace your heavy, bulky metal HVE valves with DisposEvac All-in-One HVE Tips and elimina Replace your heavy, bulky metal HVE valves with DisposEvac All-in-One HVE Tips and eliminate the hassle and expense of maintenance and sterilization. Simply replace your existing adapter with the DisposEvac Hose Adapter and use 100% disposable DisposEvac tips to eliminate cross-contamination. Ergonomic, built-in valve opens and closes with an easy sliding action. Lightweight plastic construction reduces fatigue during long procedures. Tips may be rotated for extra convenience. Requires simple, one-time installation of hose adapter. Vented green tip. 8" long overall. 50 per bag.
Catalog Number
70-42627
Brand Name
DisposEvac All-in-One HVE Tips
Version/Model Number
70-42627
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
c9da0cf7-5518-44c1-ad78-1246ca5a66f3
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896010112
Quantity per Package
20
Contains DI Package
00723896010105
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |