MX40 Masimo Leadsets and Adapters

Basic Information

• Brand Name: MX40 Masimo Leadsets and Adapters
• Primary DI: 00884838090118
• Version / Model: ECG 5L Grabber, IEC, Masimo SpO2 , Tele
• Catalog Number: 989803202421
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-21
• Public Version: 6
• Public Version Date: 2022-11-21
• Public Version Status: Update
• Public Device Record Key: cd15947d-f095-4c10-a0a1-ca4a76f9b8b8

Device Description

ECG 5L Grabber, IEC, Masimo SpO2, Tele. MX40 Patient Cable consists of 5-wire ECG lead set with integrated 8-pin Masimo SET SpO2 connector cable. Grabber leads, IEC color coded (colored lead wires). Reusable. Cable length = 85 cm (33.5"). 1 Sales unit = 1 cable.

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
DSA	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)	Cardiovascular	870.2900	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	00884838090118	GS1

Customer Contacts

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

Storage Conditions

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