Home GUDID 00850040691023 Cardio Flow Peripheral Guide Wire
Primary DI 00850040691023
Brand Cardio Flow Peripheral Guide Wire
Company Cardio Flow, Inc.
Model GW1001
Device description Cardio Flow Peripheral Guide Wire Guidewire, 325 CM
Published 2024-06-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DQX Wire, Guide, Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQX Wire, Guide, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850040691016 Package GS1 5 In Commercial Distribution 00850040691023 Package GS1 1 In Commercial Distribution 00850040691009 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 00850040691016 00850040691016 850040691016 0850040691016 00850040691023 00850040691023 850040691023 0850040691023 00850040691009 00850040691009 850040691009 0850040691009
GMDN Terms# Term, Definition table Term Definition Peripheral vascular guidewire, manual A long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Guidewire Length 325 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 50 Percent (%) Relative Humidity Handling Environment Temperature 15 Degrees Celsius 35 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 30 Percent (%) Relative Humidity 50 Percent (%) Relative Humidity Storage Environment Temperature 15 Degrees Celsius 35 Degrees Celsius
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 080505958 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850040691009 Cardio Flow Peripheral Guide Wire GW1001 2024-06-21 00850040691030 FreedomFlow Orbital Circumferential Atherectomy System H6001 2024-06-21 00850040691054 FreedomFlow Orbital Circumferential Atherectomy System H6002 2024-06-21 00850040691085 FreedomFlow Orbital Circumferential Atherectomy System H6004 2024-06-21
Other Devices Sharing Product Codes# 
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