Duns Number:618825723
Device Description: ENDOTRACHEAL TUBE CUFFED 7.0 MM WITH SUCTION PORT MURPHY EYE
Catalog Number
919970
Brand Name
KENOREX
Version/Model Number
919970
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110269,K110269,K110269
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
2eaf056e-2139-4446-a175-310888a8e9a3
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 10, 2016
Package DI Number
20851785007609
Quantity per Package
10
Contains DI Package
10851785007602
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |