AccessGUDID - DEVICE: InQwire® Amplatz (00884450239711)

GUDID

Device Identifier (DI) Information

Brand Name: InQwire® Amplatz
Version or Model: 00884450239711
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IQA520
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450239711
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184763290 *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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35094	Cardiac/peripheral vascular guidewire, single-use	A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQX	Wire, guide, catheter

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
Device Size Text, specify: Configuration-Amplatz Exchange; Tip Shape-Straight (6.0 cm) Tip; Configuration-Amplatz Exchange; Length-260 cm (102")
Device Size Text, specify: Length-260 cm (102"); Tip Shape-Straight (6.0 cm) Tip; Configuration-Amplatz Exchange; Length-260 cm (102")
Device Size Text, specify: Tip Shape-Straight (6.0 cm) Tip
Device Size Text, specify: Configuration-Amplatz Exchange
Device Size Text, specify: Length-260 cm (102")

Device Record Status

Public Device Record Key: 7f149e7f-55ce-489d-96ea-5465e3b95a5b
Public Version Date: April 25, 2025
Public Version Number: 5
DI Record Publish Date: January 15, 2018