Duns Number:184763290
Catalog Number
90129-303/C
Brand Name
AERO DV®
Version/Model Number
00884450030981
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JCT
Product Code Name
Prosthesis, tracheal, expandable
Public Device Record Key
9322ea27-884d-446c-b762-5c52a847b060
Public Version Date
November 08, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
10884450030988
Quantity per Package
1
Contains DI Package
00884450030981
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |