AccessGUDID - DEVICE: Welch Allyn, Inc. (00732094260960)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00732094260960
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 198227881 *Terms of Use

Device Description: XScribe 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 ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer, (includes starter pack of full-grid paper - A4), XScribe premium transport cart with base, keyboard tray, storage shelf, lar

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):	No
Over the Counter (OTC):	Yes
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?
35447	Cardiopulmonary stress exercise monitoring system computer	A dedicated computer with a specific software package installed intended to be used to interpret the various physiological parameters and waveforms generated during stress exercise testing of a patient while connected to a stress exercise monitoring system. These signals are provided by appropriate interfaced stress testing devices (e.g., an ergometer) using predefined pattern recognition techniques. The registered signals are compared to pre-established diagnostic criteria.	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: c5fa9aed-c7ac-461c-9a37-0ac6d4d02870
Public Version Date: June 27, 2022
Public Version Number: 2
DI Record Publish Date: July 24, 2019