Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094318166
• Version / Model: 901144
• Catalog Number: XSCRIBE-6XC-XXBXX
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-01
• Public Version: 2
• Public Version Date: 2022-06-27
• Public Version Status: Update
• Public Device Record Key: c02ea08e-1230-4fd5-a02f-04e224828d66

Device Description

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DPS	Electrocardiograph	Cardiovascular	870.2340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00732094318166	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]