AccessGUDID - DEVICE: Corsair Armet (04547327108225)

GUDID

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Device Identifier (DI) Information

Brand Name: Corsair Armet
Version or Model: WCSAR150-14N
Catalog Number:
Company Name: ASAHI INTECC CO., LTD.

Primary DI Number: 04547327108225
Issuing Agency: GS1
Device Count: 1

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Peripheral/coronary vascular infusion catheter	A sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral and coronary vasculature; it may also facilitate the placement and exchange of guidewires and other interventional devices. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include an inflatable balloon designed to isolate a specific region of coronary or peripheral vasculature from blood flow while allowing infusion into that region. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Peripheral/coronary vascular infusion catheter

A sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral and coronary vasculature; it may also facilitate the placement and exchange of guidewires and other interventional devices. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include an inflatable balloon designed to isolate a specific region of coronary or peripheral vasculature from blood flow while allowing infusion into that region. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
DQY	CATHETER, PERCUTANEOUS

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Catheter Gauge: 2.3 French
Length: 150 Centimeter

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 16, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
24547327108229	1	04547327108225		In Commercial Distribution

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: Corsair Armet (04547327108225)