Duns Number:058614483
Device Description: Hi-Lo Oral/Nasal Tracheal Tube,Lanz System
Catalog Number
96117
Brand Name
Mallinckrodt
Version/Model Number
96117
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)
Yes
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
K791045,K791045,K791045
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
90246bf4-bf62-4a3e-b86e-3943f47c82d9
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
August 31, 2015
Package DI Number
60884522007448
Quantity per Package
10
Contains DI Package
50884522007441
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 |