Duns Number:058614483
Device Description: Oral/Nasal Tracheal Tube Cuffed,Reinforced, Murphy Eye
Catalog Number
-
Brand Name
Mallinckrodt
Version/Model Number
86553
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
K790575,K790575
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
f47e51c5-28bf-429c-9dfc-97a1f69216de
Public Version Date
February 17, 2022
Public Version Number
4
DI Record Publish Date
August 30, 2015
Package DI Number
20884522043387
Quantity per Package
5
Contains DI Package
10884522043380
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 |