Clear Choice Adapter

Basic Information

• Brand Name: Clear Choice Adapter
• Primary DI: 10812345022176
• Version / Model: 9325-003-50
• Company Name: MORTARA INSTRUMENT, INC.
• Labeler DUNS: 062046149
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2020-06-29
• Public Version Status: Update
• Public Device Record Key: 5efeb430-26be-4fb3-8fe1-bef574588467

Device Description

ECG Adapter

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: Labeling does not contain MRI Safety Information
• 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
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	870.2900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60635	Electrocardiographic electrode connector	A small clip designed to enable an electrical connection between an electrocardiographic electrode and an electrocardiographic lead wire. It is typically made of plastic materials, with a metallic part to provide electrical connection, and can be manually applied to a dedicated area of a disk-like electrode that is placed on the patient’s skin, with a socket at the other end for a plug on the lead. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10812345022176	GS1
Unit of Use	00812345022179	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080605	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: – 158 Degrees Fahrenheit