Duns Number:058614483
Device Description: Oral/Nasal Tracheal Tube Cuffless
Catalog Number
-
Brand Name
Mallinckrodt
Version/Model Number
86462
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 24, 2021
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
ee53d703-0e55-4cb4-a2f3-2eaf190e25ec
Public Version Date
August 16, 2022
Public Version Number
7
DI Record Publish Date
August 30, 2015
Package DI Number
40884522005464
Quantity per Package
10
Contains DI Package
60884522005468
Package Discontinue Date
December 24, 2021
Package Status
Not in Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |