Duns Number:174508630
Device Description: Passy-Muir® Low Profile Tracheostomy & Ventilator Swallowing and Speaking Valve PMV® 2001 Passy-Muir® Low Profile Tracheostomy & Ventilator Swallowing and Speaking Valve PMV® 2001 (Purple Color™)
Catalog Number
PMV 2001
Brand Name
Passy-Muir
Version/Model Number
PMV 2001
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K962714
Product Code
JOH
Product Code Name
Tube Tracheostomy And Tube Cuff
Public Device Record Key
6adcfe08-c940-4950-a906-76d6a8e9c3a7
Public Version Date
August 23, 2018
Public Version Number
4
DI Record Publish Date
September 16, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |