Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094350753
• Version / Model: 901143
• Catalog Number: HSERV-6BA-XXXXB
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-27
• Public Version: 2
• Public Version Date: 2022-06-28
• Public Version Status: Update
• Public Device Record Key: 6dcdb6b4-c31f-4abc-90fa-4f5cdf90db9a

Device Description

HS6 SERVER RX KIT DICOM PDF XML

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: 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
MLO	ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41651	Electrocardiographic long-term ambulatory recording analyser application software	A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00732094350753	GS1

Customer Contacts

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