Duns Number:609397224
Device Description: SunWrap™ Compression System provides localized compression and visualization through a cen SunWrap™ Compression System provides localized compression and visualization through a central transparent bladder covering the dressed site. SunWrap™ Compression systems provides localized compression and visualization to manage access site bleeding post-hemodialysis or any covered wound that would require compression to control bleeding.
Catalog Number
SWMAXL
Brand Name
SunWrap Mini 12 Arm Wrap Extra Large
Version/Model Number
AW4050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 22, 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
-
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
fa13cdae-f5c6-466a-9ccb-87d89cb7fd14
Public Version Date
May 09, 2022
Public Version Number
1
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 |