Duns Number:606864184
Device Description: 7.0mm ID oral/nasal endotracheal tube with inflatable rounded cuff, Magill curve, radiopaq 7.0mm ID oral/nasal endotracheal tube with inflatable rounded cuff, Magill curve, radiopaque line and smooth Murphy tip
Catalog Number
121070
Brand Name
EndoFlex
Version/Model Number
Oral Nasal 121070
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
K031794,K031794
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
a7785473-2875-44f0-9f9c-f755352b1fe5
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
June 01, 2016
Package DI Number
10182151000539
Quantity per Package
10
Contains DI Package
00182151000532
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |