Duns Number:058614483
Device Description: Pediatric Specialized Tracheostomy Tube
Catalog Number
M4.5 PED
Brand Name
Shiley
Version/Model Number
M4.5 PED
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 15, 2017
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
46349671-2b30-44e5-b859-e3dab59ffb89
Public Version Date
April 29, 2022
Public Version Number
5
DI Record Publish Date
December 11, 2015
Package DI Number
10884521112902
Quantity per Package
99
Contains DI Package
30884521112906
Package Discontinue Date
September 02, 2015
Package Status
Not in Commercial Distribution
Package Type
CS
| 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 |