AccessGUDID - DEVICE: Welch Allyn, Inc. (00732094350869)

GUDID

Device Identifier (DI) Information

Brand Name: Welch Allyn, Inc.
Version or Model: 901144
Commercial Distribution Status: In Commercial Distribution
Catalog Number: QS-6ED-AFEAX
Company Name: WELCH ALLYN, INC.

Primary DI Number: 00732094350869
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 198227881 *Terms of Use

Device Description: Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - A4), Q-Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; I

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:	No
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?
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPS	Electrocardiograph

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: No
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: cc3be33c-875d-43e4-9ff2-3a44716d9bf9
Public Version Date: June 06, 2024
Public Version Number: 3
DI Record Publish Date: September 10, 2021