Duns Number:066087031
Device Description: Endotracheal Tube, Standard Type, Uncuffed, Size = 3.5 mm Inner Diameter.
Catalog Number
ETNU355
Brand Name
Endure
Version/Model Number
ETNU3551217
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K140228,K140228,K140228
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
3c08f306-e225-4f22-aba0-8db5a454b6d9
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
February 21, 2018
Package DI Number
B531ETNU3552
Quantity per Package
10
Contains DI Package
B531ETNU3551
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |