LUMISCOPE

GUDID M36867003

Portable Ultrasonic Nebulizer

GF HEALTH PRODUCTS, INC.

Benchtop nebulizer, non-heated

• Primary Device ID: M36867003
• NIH Device Record Key: cfd3c921-803d-4fdd-bdbd-7b74f582e7ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMISCOPE
• Version Model Number: 6700
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com
• Phone: 770-368-4700
• Email: cs@grahamfield.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M36867001 [Primary]
HIBCC	M36867002 [Package]; Contains: M36867001; Package: [6 Units]; In Commercial Distribution
HIBCC	M36867003 [Package]; Contains: M36867002; Package: [8 Units]; In Commercial Distribution

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• 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