Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094069891
• Version / Model: 901047
• Catalog Number: 101457
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 6
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 7d189158-197b-4466-acdb-d5df1ffbd4af
• Distribution End Date: 2021-02-15

Device Description

Welch Allyn CardioPerfect Workstation with PCE-210 PC-Based 12-Lead Exercise Stress Electrocardiograph, Automatic ECG Interpretation, AHA ECG Cable, Treadmill, Personal Computer with Printer and Cart

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
36888	Blood pressure ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient (typically on the arm or wrist) during daily activities for 24-hour recording of blood pressure; it is not intended to detect cardiac arrythmias. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. The device typically incorporates display and controls and may include a cuff with connection tubing and/or calibration device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00732094069891	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141582	000