Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094265262
• Version / Model: 901133
• Catalog Number: ELI380-DBX32
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-24
• Public Version: 3
• Public Version Date: 2022-06-27
• Public Version Status: Update
• Public Device Record Key: 45299016-210a-42e1-89f2-c0df2cf8d8ee

Device Description

ELI380 12-Lead Multi-Channel Electrocardiograph - Capacitive color touchscreen 17 in. swivel display (ERGO) with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Standard Connectivity includes WLAN, LAN, and USB; AM12 Wired Acquisition Module (for use with Quickels Decapus III or greater

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
16231	Electrocardiograph, professional, multichannel	A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00732094265262	GS1

Customer Contacts

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