CLARAVUE

Basic Information

• Brand Name: CLARAVUE
• Primary DI: 03700506300136
• Version / Model: CLARAVUE PM D12 RT US
• Catalog Number: 50602-US
• Company Name: NISSHA MEDICAL TECHNOLOGIES SAS
• Labeler DUNS: 391906658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-19
• Public Version: 2
• Public Version Date: 2023-04-06
• Public Version Status: Update
• Public Device Record Key: 1a06e738-7f20-44c1-b0d5-fcdcd6a5fcd7

Device Description

CLARAVUE PM D12 RT US

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DRX	Electrode, Electrocardiograph	Cardiovascular	870.2360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35035	Electrocardiographic electrode, single-use	A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700506300136	GS1
Package	13700506300133	GS1	Box	25	In Commercial Distribution
Package	23700506300130	GS1	Case	300	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101685	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 59 – 95 Degrees Fahrenheit