Caremed

Basic Information

• Brand Name: Caremed
• Primary DI: 06970758507615
• Version / Model: AD-BA-10
• Catalog Number: AD-BA-10
• Company Name: Shenzhen Caremed Medical Technology Co., Ltd.
• Labeler DUNS: 544335718
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-30
• Public Version: 1
• Public Version Date: 2019-11-07
• Public Version Status: New
• Public Device Record Key: 56b47c89-47e7-4a82-8460-2d3409051be4
• Distribution End Date: 2019-10-30

Device Description

Caremed ECG lead wire

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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	06970758507615	GS1

Premarket Submissions

Submission Number	Supplement Number
K153188	000