Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094090697
• Version / Model: 901060
• Catalog Number: 64NXPX-B
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-05
• Public Version: 8
• Public Version Date: 2022-06-27
• Public Version Status: Update
• Public Device Record Key: c82b932e-c224-474c-b511-1744323c71ef

Device Description

Welch Allyn Connex 6400 Vital Signs Monitor with Nellcor SpO2, Internal Printer, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, BP Averaging, Nurse Call, Four USB Ports for Accessories, Radio Ready; 100-240 V, 50-60 Hz AC, IEC Plug Type-B

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
MWI	MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36872	Multiple vital physiological parameter monitoring system, clinical	An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00732094090697	GS1

Customer Contacts

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