Duns Number:058614483
Device Description: Tracheal Tube Cuffless Reinforced
Catalog Number
-
Brand Name
Shiley
Version/Model Number
86541
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
K841872,K841872,K841872
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
0bd289d1-5826-4eeb-9baf-89f347b6c327
Public Version Date
June 15, 2022
Public Version Number
8
DI Record Publish Date
March 21, 2018
Package DI Number
40884522029156
Quantity per Package
10
Contains DI Package
50884522029153
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 |