Duns Number:832426782
Device Description: TRACHEAL TUBE - CUFFED 6.0mm ID
Catalog Number
ZZ-0269
Brand Name
Tracheal Tube
Version/Model Number
ZZ-0269
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"
Yes
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
K042684,K042684,K042684
Product Code
BTO
Product Code Name
Tube, Tracheostomy (W/Wo Connector)
Public Device Record Key
509cae7d-350a-47fe-bcba-b2a59a006e61
Public Version Date
June 05, 2020
Public Version Number
7
DI Record Publish Date
October 06, 2017
Package DI Number
20842209105025
Quantity per Package
10
Contains DI Package
10842209105028
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |