Home GUDID 00870053000162
HemCon® ChitoPulse™, 15 inch
Primary DI 00870053000162
Brand HemCon® ChitoPulse™, 15 inch
Company TRICOL BIOMEDICAL, INC.
Model 1
Catalog number 1097
Device description 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.
Published 2020-08-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name DXC Clamp, Vascular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DXC Clamp, Vascular Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20870053000166 Package GS1 5 In Commercial Distribution 50870053000167 Package GS1 10 In Commercial Distribution 00870053000162 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20870053000166 20870053000166 50870053000167 50870053000167 00870053000162 00870053000162 870053000162 0870053000162
GMDN Terms# Term, Definition table Term Definition Radial artery compression device A device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 11 Degrees Celsius 26 Degrees Celsius
Regulatory Flags# DUNS number 080240553 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00870053000018 "ChitoGauze®XR PRO 3"" x 4 yds Prometheus" 1 1089 2021-01-27 00870053000049 HemCon ChitoDot®, 3/4in 1 1093 2021-04-14 00870053000131 "ChitoGauze®XR PRO 3"" x 4 yds" 1 1090 2021-01-27 00870053000292 ChitoGauze®, OTC, 3in x 48in 1 1030 2021-04-14 00870053000308 ChitoGauzeXL, OTC, 3in x 4yd 1 1025 2021-04-14 00870053000315 HemCon ChitoGauze XR2 Pro, 3in x 4yd 1 1101 2021-04-14 00870053000339 HemCon® OneStop™ Bandage, 2in x 2in 1 1105 2021-05-05 00870053000353 HemCon® OneStop™ Bandage, 2in x 2in 1 1114 2020-10-15 00870053000407 HemCon® OneStop® Vascular, 2in x 2in 1 1103 2022-04-05 00870053000414 HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-Slit 1 1104 2022-04-05 00870053000568 ChitoGauzeXR PRO, 3in x 4yds 1 1020 2024-05-30 00870053001015 HemCon® Bandage PRO, 4in x 4in 1 1003 2020-10-14 00870053001121 HemCon ChitoFlex®, 1in x 3in 1 1008 2021-04-14 00870053001299 HemCon® Patch PRO, 1.5in x 1.5in 1 1004 2020-10-14 00870053001855 HemCon® Patch PRO, 2in x 2in 1 1005 2020-10-14 00870053001268 HemCon® Strip PRO, 1in x 4in 1 2021-07-09 00870053000117 GuardaCare®XR Surgical, 4in x 4in, 8ply 1 1032 2021-07-08 00870053000360 HemCon® OneStop™ Bandage, 2in x 2in, OTC 1 1112 2021-05-05 00870053001367 GuardaCare® PRO, 4in x 4in, 8ply 1 1013 2021-04-14 00870053001350 HemCon GuardaCare® PRO, 2in x 2in, 8ply 1 1012 2020-12-10
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