Duns Number:609397224
Device Description: The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermitten
Catalog Number
DV-FMLB
Brand Name
AeroDVx™, Medium/Large Flex Bilateral
Version/Model Number
Medium/Large Flex Bilateral
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 31, 2030
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
K183349
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
25a5e076-5a70-40a1-99a9-2723291d326f
Public Version Date
July 29, 2021
Public Version Number
1
DI Record Publish Date
July 21, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |