LUMISCOPE

GUDID M368SW10002

Standard TENS Unit

GF HEALTH PRODUCTS, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: M368SW10002
• NIH Device Record Key: b67907c0-bd56-4fb0-9658-5aaffdc615a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMISCOPE
• Version Model Number: SW-1000
• Company DUNS: 132016168
• Company Name: GF HEALTH PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: false

Customer Support Contacts

• Phone: 770-368-4700
• Email: cs@grahamfield.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M368SW10001 [Primary]
HIBCC	M368SW10002 [Package]; Contains: M368SW10001; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002874

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-08-31

On-Brand Devices [LUMISCOPE]

• M36811372: Advanced Upper Arm Blood Pressure Monitor
• M368SW10002: Standard TENS Unit
• M368LUMITENS2: Economy TENS Unit
• M3682000T1: Deluxe TENS Unit
• M36811333: Automatic Blood Pressure Monitor
• M3682040061: #NURSES STETH BLUE LOT#
• M36867003: Portable Ultrasonic Nebulizer
• M36811431: Automatic Wrist Blood Pressure Monitor