Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094357066
• Version / Model: 901144
• Catalog Number: QS-6KA-ACDAB
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-18
• Public Version: 1
• Public Version Date: 2024-07-26
• Public Version Status: New
• Public Device Record Key: 82a6381a-c109-4a95-ab36-82d77461a793

Device Description

QS6 WAM TTL TMX SYS Z200 PCRT AHA DICOM

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• Has Lot/Batch Number: Yes
• 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	00732094357066	GS1

Customer Contacts

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