Duns Number:787855907
Device Description: Start-Up Kit with the following components: Multi-Port ULPA Filter - 00815198012489, Foot Start-Up Kit with the following components: Multi-Port ULPA Filter - 00815198012489, Footswitch - 00851136002969, EZLink - 00815198011079, Reducer Fitting - 00851136002976, Smoke Evacuation Tubing with Connectors - 00851136002150, Y-Adapter - 00851136002365, PlumePort SE - 00851136002433, PlumePort SEV - 00851136002587, Smoke Evacuation Tubing - 00851136002235, PenAdapt - 00851136002143, and Smoke Evacuation Tubing with Wand - 00851136002068
Catalog Number
-
Brand Name
TeleVac2
Version/Model Number
5000194
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAZ
Product Code Name
Tubing, Noninvasive
Public Device Record Key
3c4dad64-bdc3-4b67-8537-9f4459b2250f
Public Version Date
April 22, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 104 |