AccessGUDID - DEVICE: Zurich Pressure Guidewire System (00850022994005)

GUDID

Device Identifier (DI) Information

Brand Name: Zurich Pressure Guidewire System
Version or Model: Model 100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 308
Company Name: ZURICH MEDICAL INC.

Primary DI Number: 00850022994005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080001248 *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

[?]

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
47486	Intravascular haemodynamic monitoring system guidewire	A sterile, steerable, component of a haemodynamics monitoring system for the in vivo measurement of blood pressure and/or blood flow velocity in all blood vessels, including the coronary and peripheral arteries, during diagnostic and/or interventional procedures. It typically consists of a long, thin, flexible rod that has built-in pressure/flow measuring transducers/sensors at its working end, and a torque device to facilitate navigation through the vasculature; it has a handle at the proximal end and a cable(s) to connect to the monitoring system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXO	Transducer, Pressure, Catheter Tip
DQK	Computer, Diagnostic, Programmable
DSK	Computer, Blood-Pressure
DQX	Wire, Guide, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190852	000

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
No Device Sizes

Device Record Status

Public Device Record Key: b9a51682-4c3b-4613-84d8-41451ffa0c3e
Public Version Date: September 29, 2020
Public Version Number: 1
DI Record Publish Date: September 21, 2020