MR Patient Care Standard ECG 3.0 Cable AAMI

Basic Information

• Brand Name: MR Patient Care Standard ECG 3.0 Cable AAMI
• Primary DI: 00884838102453
• Version / Model: Standard ECG 3.0 Cable AAMI
• Catalog Number: 989803193731
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 013649151
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-13
• Public Version: 4
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: 1d06e3df-b1a8-44b2-833c-0d77a0a91a56

Device Description

ECG lead cable designed for use with 3rd-generation wireless ECG module and Standard Quadtrodes (AAMI coded leads.)

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: MR Conditional
• 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
MWI	Monitor, physiological, patient (without arrhythmia detection or alarms)	Cardiovascular	870.2300	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	00884838102453	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 570 – 1020 millibar
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57 – 102 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 429 – 765 Millimeter of Mercury
• Type: Storage Environment Humidity
• Temperature Range: 5 – 80 Percent (%) Relative Humidity