Duns Number:041674552
Device Description: ET Tube, 8.0mm, Cuffed
Catalog Number
-
Brand Name
MedSource ET Tube, 8.0mm, Cuffed
Version/Model Number
MS-23280
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"
-
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
-
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
c002e218-7493-4fe4-8d01-314a504dfb07
Public Version Date
April 25, 2022
Public Version Number
4
DI Record Publish Date
June 15, 2016
Package DI Number
10816703020187
Quantity per Package
10
Contains DI Package
00816703020180
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 | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |