Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094063448
• Version / Model: 901047
• Catalog Number: 104060
• 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: 4
• Public Version Date: 2021-01-26
• Public Version Status: Update
• Public Device Record Key: 0be5f7d9-0a21-4b69-b60b-5bea26c292a7
• Distribution End Date: 2021-01-25

Device Description

Welch Allyn CardioPerfect Workstation with PC-Based 12-Lead Resting Electrocardiograph, Automatic ECG Interpretation, AHA ECG Cable, PC-Based SpiroPerfect Spirometer, 64-Bit Operating System

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: 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
BZG	SPIROMETER, DIAGNOSTIC	Anesthesiology	868.1840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45084	Ophthalmic/otologic diagnostic set	A collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00732094063448	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072449	000