LUMISCOPE

GUDID M36811372

Advanced Upper Arm Blood Pressure Monitor

GF HEALTH PRODUCTS, INC.

Patient monitoring system module, blood pressure, noninvasive

• Primary Device ID: M36811372
• NIH Device Record Key: 916582df-62a6-4903-9dac-6db6d42f011e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMISCOPE
• Version Model Number: 1137
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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 -4 Degrees Celsius and 140 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M36811371 [Primary]
HIBCC	M36811372 [Package]; Contains: M36811371; Package: [5 Units]; In Commercial Distribution
HIBCC	M36811373 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-18
• 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