MX40 Masimo Leadsets and Adapters

Basic Information

• Brand Name: MX40 Masimo Leadsets and Adapters
• Primary DI: 00884838090088
• Version / Model: MX40 Adapter 5-Lead + Masimo SpO2
• Catalog Number: 989803202381
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-23
• Public Version: 1
• Public Version Date: 2022-05-31
• Public Version Status: New
• Public Device Record Key: 87fab46b-bb35-4452-98af-2925f3e209ac

Device Description

MX40 Adapter 5-Lead + Masimo SpO2. For use with MX Telemetry systems. Supports IntelliVue connector style disposable and reusable ECG leadsets and DIN prewired electrodes on the MX Telemetry Systems. Supports Masimo SpO2 accessories defined for MX Telemetry systems. 5 lead ECG + Masimo SET SpO2. Quantity 1, reusable.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838090088	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -40 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity