Duns Number:609397224
Device Description: The AeroWrap ™ Bilateral Kit System is comprised of two gradient compression sleeves, and The AeroWrap ™ Bilateral Kit System is comprised of two gradient compression sleeves, and a hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ kit system gradient compression sleeves are non-sterile single patient use medical device. The AeroWrap™ Bilateral Kit Gradient Compression Sleeves contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s legs 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
AWB-LSB
Brand Name
Aero-Wrap™ Bilateral Kit, Small
Version/Model Number
AW6180-03
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)
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
4aa486de-c91e-4d2a-a551-a4baaf4db89f
Public Version Date
June 23, 2022
Public Version Number
2
DI Record Publish Date
April 29, 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 |