Duns Number:825673239
Device Description: AMSure® Endotracheal Tubewith Cuff, High Volume, Low Pressure, Radiopaque Line
Catalog Number
AS72050
Brand Name
AMSure® Endotracheal Tube
Version/Model Number
1
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
K042683,K042683,K042683
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
b3397c8b-41e6-4736-a5f8-cf93fa7c91c4
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
30704411002448
Quantity per Package
10
Contains DI Package
10704411002444
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |