BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

ECG Cables and Leadsets

DI: 00884838011663 · Model: CBL 3 Leadset, Grabber, IEC, OR · Philips Medizin Systeme Böblingen GmbH

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: ECG Cables and Leadsets
Primary DI: 00884838011663
Version / Model: CBL 3 Leadset, Grabber, IEC, OR
Catalog Number: 989803145141
Company Name: Philips Medizin Systeme Böblingen GmbH
Labeler DUNS: 314101143
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-12-26
Public Version: 10
Public Version Date: 2025-12-31
Public Version Status: Update
Public Device Record Key: 34bf6690-039e-4aaa-9aaa-c36aea3d58b4
Distribution End Date: 2025-12-31

Device Description

3 Leadset, Grabber, IEC, OR

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 Unsafe
Direct Marking Exempt: No
PM Exempt: Yes
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
IKD	CABLE, ELECTRODE	Physical Medicine	890.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35562	Electrocardiographic lead set, reusable	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 (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	00884838011663	GS1

Customer Contacts

Phone: +1(999)999-9999
Email: [email protected]

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: 15 – 95 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -20 – 70 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: -4 – 158 Degrees Fahrenheit
Type: Storage Environment Atmospheric Pressure
Temperature Range: 10 – 108 KiloPascal