Duns Number:080216804
Device Description: Pediatric Tracheostomy Mask, 22mm Swivel Tubing Connector & One Side Snap. The tracheostom Pediatric Tracheostomy Mask, 22mm Swivel Tubing Connector & One Side Snap. The tracheostomy mask is used to administer aerosol or oxygen into tracheostomy of a surgical patient. It is intended for channeling gases for the purpose of administration of oxygen to patient. It is used to connect to an active medical device.
Catalog Number
RTG-04017
Brand Name
Trach O-Life
Version/Model Number
RTG-04017
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
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
BYG
Product Code Name
Mask, Oxygen
Public Device Record Key
c432e2c0-d3b6-4269-9bdb-9f298c5e0fa0
Public Version Date
May 11, 2020
Public Version Number
2
DI Record Publish Date
February 25, 2019
Package DI Number
10850108006896
Quantity per Package
50
Contains DI Package
00850108006899
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |