Duns Number:058614483
Device Description: Hi-Lo Oral/Nasal Tracheal Tube,Lanz System
Catalog Number
-
Brand Name
Mallinckrodt
Version/Model Number
96112
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 2019
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
c1b03f13-b47c-456b-b77e-42e28970d7cd
Public Version Date
September 14, 2022
Public Version Number
6
DI Record Publish Date
November 11, 2016
Package DI Number
60884522007400
Quantity per Package
10
Contains DI Package
40884522007406
Package Discontinue Date
October 02, 2019
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 |