Duns Number:058614483
Device Description: Oral/Nasal Tracheal Tube Cuffless
Catalog Number
86463
Brand Name
Mallinckrodt
Version/Model Number
86463
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
-
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
598c4e9e-1098-4a26-9718-7ca1c3e47b8d
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
August 30, 2015
Package DI Number
50884522005478
Quantity per Package
10
Contains DI Package
60884522005475
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 |