Duns Number:058614483
Device Description: Speaking Valve,O2 Port
Catalog Number
-
Brand Name
Shiley
Version/Model Number
SSVO
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
-
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
K945407,K945407,K945407
Product Code
BTO
Product Code Name
Tube, tracheostomy (w/wo connector)
Public Device Record Key
fa779d3f-0ad3-405c-8e40-511de0fdb07d
Public Version Date
May 27, 2022
Public Version Number
6
DI Record Publish Date
October 12, 2015
Package DI Number
10884522007733
Quantity per Package
50
Contains DI Package
50884522007731
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |