LUMISCOPE

GUDID M368100040HG1

Aneroid Blood Pressure Monitor

GF HEALTH PRODUCTS, INC.

Aneroid manual sphygmomanometer

• Primary Device ID: M368100040HG1
• NIH Device Record Key: 08d389c3-7d69-41c9-88e3-7957c04d345c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMISCOPE
• Version Model Number: 100-040HG
• 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: 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M368100040HG1 [Primary]
HIBCC	M368100040HG2 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122259

FDA Product Code

• DXQ: Blood Pressure Cuff

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: 2024-12-16
• Device Publish Date: 2016-08-31

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• M36811333: Automatic Blood Pressure Monitor
• M3682040061: #NURSES STETH BLUE LOT#
• M36867003: Portable Ultrasonic Nebulizer
• M36811431: Automatic Wrist Blood Pressure Monitor
• M368100510LA1: Deluxe Aneroid Blood Pressure Monitor
• M3681005101: Deluxe Aneroid Blood Pressure Monitor
• M368100040P1: Aneroid Blood Pressure Monitor
• M368100040ORC1: Aneroid Blood Pressure Monitor
• M368100040HG1: Aneroid Blood Pressure Monitor
• M368100040GRP1: Aneroid Blood Pressure Monitor
• M368100040DB1: Aneroid Blood Pressure Monitor
• M368100040BUR1: Aneroid Blood Pressure Monitor
• M368100040BK1: Aneroid Blood Pressure Monitor
• M368100001N1: Aneroid Sphygmomanometer
• M3681000011: Aneroid Sphygmomanometer