Omron TENS Total Power + Heat for Canada PM800CAN

GUDID 10073796800311

Omron TENS Total Power + Heat is a portable, battery-operated device that is designed to relieve muscle and joint pain.

Omron Healthcare, Inc.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 10073796800311
• NIH Device Record Key: 9147df99-7c44-47b6-8ae6-0db0ba873b06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron TENS Total Power + Heat for Canada
• Version Model Number: PM800CAN
• Catalog Number: PM800CAN
• Company DUNS: 054318779
• Company Name: Omron Healthcare, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-634-4350
• Email: ohiquality@omron.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796800314 [Primary]
GS1	10073796800311 [Package]; Contains: 00073796800314; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181992

FDA Product Code

• NYN: Stimulator, Electrical, Transcutaneous, For Arthritis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-23
• Device Publish Date: 2020-01-15

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