Duns Number:058614483
Device Description: Oral/Nasal Tracheal Tube Cuffless
Catalog Number
-
Brand Name
Mallinckrodt
Version/Model Number
86467
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 20, 2020
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
f5e507d0-d172-431d-867c-9c55e590b959
Public Version Date
September 23, 2022
Public Version Number
4
DI Record Publish Date
November 11, 2016
Package DI Number
50884522005515
Quantity per Package
100
Contains DI Package
60884522005512
Package Discontinue Date
November 20, 2020
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 |