Multi-Link™

Basic Information

• Brand Name: Multi-Link™
• Primary DI: 10889483578018
• Version / Model: 2090101-813
• Catalog Number: 2090101-813
• Company Name: AirLife Finland Oy
• Labeler DUNS: 368457563
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-31
• Public Version: 1
• Public Version Date: 2025-04-08
• Public Version Status: New
• Public Device Record Key: cc2f0fe2-b27b-4e13-9ce7-ef33057993d0

Device Description

Multi-Link™ X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set 6-Lead Set for Nihon Kohden, Grabber, AHA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	870.2900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61821	Electrocardiographic lead set, single-use	A collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20889483578015	GS1	Case	10	In Commercial Distribution
Primary	10889483578018	GS1
Previous	10190752182752	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163316	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -22 – 158 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -30 – 70 Degrees Celsius