Duns Number:058614483
Device Description: Neonatal Tracheostomy Tube Cuffless
Catalog Number
-
Brand Name
Shiley
Version/Model Number
3.5 NEO
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
K945513,K945513
Product Code
JOH
Product Code Name
Tube tracheostomy and tube cuff
Public Device Record Key
093fb21b-6742-486d-9060-77744f13e6c9
Public Version Date
July 13, 2022
Public Version Number
6
DI Record Publish Date
September 15, 2015
Package DI Number
20884522026663
Quantity per Package
108
Contains DI Package
30884522026660
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 |