Duns Number:058614483
Device Description: Pediatric Tracheostomy Tube Cuffless Disposable, Bedside Tray
Catalog Number
-
Brand Name
Shiley
Version/Model Number
4.0PEF-P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2021
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
Yes
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
K182861,K182861
Product Code
JOH
Product Code Name
Tube tracheostomy and tube cuff
Public Device Record Key
ec03e761-45fd-4ae9-9f76-3999a7088fac
Public Version Date
February 01, 2022
Public Version Number
2
DI Record Publish Date
October 05, 2021
Package DI Number
20884521177205
Quantity per Package
24
Contains DI Package
10884521177208
Package Discontinue Date
March 31, 2021
Package Status
Not 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 |