Duns Number:058614483
Device Description: Tracheostomy Tube XLT Cuffed,Distal with Disposable Inner Cannula
Catalog Number
-
Brand Name
Shiley
Version/Model Number
80XLTCD
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
K051416,K051416
Product Code
JOH
Product Code Name
Tube tracheostomy and tube cuff
Public Device Record Key
d78c57f4-85db-4a15-8bd8-2c21f1b32c1c
Public Version Date
July 13, 2022
Public Version Number
6
DI Record Publish Date
August 28, 2015
Package DI Number
30884522028176
Quantity per Package
30
Contains DI Package
20884522028179
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 |