Changke Connect

Basic Information

• Brand Name: Changke Connect
• Primary DI: 16973874210138
• Version / Model: P01-001-00573
• Company Name: Shenzhen Changke Connect Electronics Co., Ltd.
• Labeler DUNS: 529906512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-04
• Public Version: 3
• Public Version Date: 2022-05-12
• Public Version Status: Update
• Public Device Record Key: 2f8070c9-0396-443b-980a-9605a88a63d2

Device Description

Set of 20pcs products in a box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
61821	Electrocardiographic lead set, single-use	A collection of non-sterile, 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 to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	16973874210138	GS1

Premarket Submissions

Submission Number	Supplement Number
K200026	000