Duns Number:609397224
Device Description: The AeroWrap ™ Flex System is comprised of a gradient compression sleeve, and hand pump to The AeroWrap ™ Flex System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy or DVT Prophylaxis.The AeroWrap™ Flex gradient compression sleeve is a non-sterile single patient use medical device. The AeroWrap™ Flex Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg from the ankle to the knee. An inflation source is attached to the inflation valve on the sleeve. There is a inflation source provided: a hand pump to provide static compression. The system is intended for hospital and outpatient use.
Catalog Number
MS-LF
Brand Name
AeroWrap™ Flex Large
Version/Model Number
Large Flex
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070457
Product Code
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
0b498555-5d36-4fd5-8dac-e0d0a431ebee
Public Version Date
June 23, 2022
Public Version Number
2
DI Record Publish Date
April 15, 2022
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 |