Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets

Basic Information

• Brand Name: Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets
• Primary DI: 20884838114016
• Version / Model: 5 lead set Disposable, Bedside, AAMI
• Catalog Number: 989803173131
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2024-09-16
• Public Version: 2
• Public Version Date: 2025-12-03
• Public Version Status: Update
• Public Device Record Key: 11e73bb1-6d05-472d-a8c7-b204bccfbfe7

Device Description

5-Lead Set, disposable, for single patient use, to measure bedside ECG. AAMI color coded grabbers. Round (rd) peelable ribbon style wires. Wire length: 3,3ft (1m). For use with trunk cables: M1668A, M1663A and M1949A. 1 Sales Unit = 20 single wrapped lead sets

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: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• 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
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
Unit of Use	00884838114012	GS1
Primary	20884838114016	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 10 – 108 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity