Duns Number:058614483
Device Description: Oral/Nasal Tracheal Tube,Seal Guard, Murphy Eye
Catalog Number
-
Brand Name
Mallinckrodt
Version/Model Number
109870
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082520,K082520
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
2d274d57-ebe4-40ee-b38c-f3879643ee33
Public Version Date
November 11, 2021
Public Version Number
5
DI Record Publish Date
August 28, 2015
Package DI Number
20884522042373
Quantity per Package
10
Contains DI Package
10884522042376
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 |