Duns Number:356432815
Device Description: SPIRO Speaking Valve With Oxygen Nipple
Catalog Number
710-1K; 710-2K; 710-5K
Brand Name
SPIRO
Version/Model Number
710
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
K122932,K122932,K122932,K122932
Product Code
JOH
Product Code Name
Tube Tracheostomy And Tube Cuff
Public Device Record Key
65044665-f02f-46e7-aaa5-7f7c6f48d1db
Public Version Date
August 23, 2018
Public Version Number
3
DI Record Publish Date
March 31, 2018
Package DI Number
07350061231367
Quantity per Package
1
Contains DI Package
07350061231121
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Paper Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |