Duns Number:058614483
Device Description: Laser Oral Tracheal Tube Cuffless;
Catalog Number
-
Brand Name
Mallinckrodt
Version/Model Number
86400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K862666,K862666
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
ed5f8b7e-17de-46f5-a628-1eb6996fdb72
Public Version Date
May 30, 2022
Public Version Number
4
DI Record Publish Date
October 22, 2015
Package DI Number
30884522001353
Quantity per Package
5
Contains DI Package
10884522024532
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 |