Duns Number:080240553
Device Description: ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch that, when p ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch that, when positioned directly onto an access site, applies localized mechanical pressure to promote hemostasis and rapid control of bleeding. The chitosan patch acts as an adjunct to the mechanical compression provided by the adjustable strap and compression balloon to aid the control of bleeding. Using the inflation syringe, the compression applied by the device can be controlled by the user without unfastening the band, allowing gradual release of compression as hemostasis occurs. ChitoPulse™ is a single use device. Once hemostasis is achieved, the adjustable band is intended to be removed leaving the hemostatic chitosan patch in place. The hemostatic chitosan patch can be secured in place with a securement dressing and left in situ for up to 24 hrs. ChitoPulse™ also provides a barrier against bacterial penetration by a wide range of gram positive and gram negative organisms.
Catalog Number
1095
Brand Name
HemCon® ChitoPulse™, 9 inch
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
028407b0-9c1b-40ce-a917-44613665a344
Public Version Date
August 26, 2020
Public Version Number
1
DI Record Publish Date
August 18, 2020
Package DI Number
20870053000067
Quantity per Package
5
Contains DI Package
00870053000063
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
U | Unclassified | 6 |