Duns Number:355470923
Device Description: ProTrach DualCare is a combined speaking valve and heat & moisture exchanger (HME) intende ProTrach DualCare is a combined speaking valve and heat & moisture exchanger (HME) intended for tracheostomized patients using a tracheostomy tube. In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air. By turning the lid of the speaking valve into speaking mode air is re-directed to enable speech.
Catalog Number
-
Brand Name
ProTrach® DualCare™ Speaking Valve
Version/Model Number
7744
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 05, 2023
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151404
Product Code
JOH
Product Code Name
Tube Tracheostomy And Tube Cuff
Public Device Record Key
f707884e-5ba8-42e1-adab-1ae8702476bb
Public Version Date
July 18, 2022
Public Version Number
5
DI Record Publish Date
September 27, 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 | 119 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 169 |