HemCon® ChitoPulse™, 9 inch - ChitoPulse™ is a compression device incorporating - TRICOL BIOMEDICAL, INC.

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

DXC

Product Code Name

Clamp, Vascular

Device Record Status

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

Additional Identifiers

Package DI Number

20870053000067

Quantity per Package

5

Contains DI Package

00870053000063

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TRICOL BIOMEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
U Unclassified 6