AccessGUDID - DEVICE: Corsair Armet (04547327108225)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 04547327108225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 713303472 *Terms of Use

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 is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include an inflatable balloon designed specifically to isolate a specific region of coronary or peripheral vasculature from blood flow while allowing infusion into that region. It is not a peripherally-inserted central venous catheter, nor a microcatheter intended for access into superselective small vessels. 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 is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include an inflatable balloon designed specifically to isolate a specific region of coronary or peripheral vasculature from blood flow while allowing infusion into that region. It is not a peripherally-inserted central venous catheter, nor a microcatheter intended for access into superselective small vessels. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
DQY	CATHETER, PERCUTANEOUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: ac2d0366-7a30-4d44-a3b9-4691f07df8c5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016