Entropy

GUDID 00840682102964

GE Healthcare Finland Oy

Analytical scalp lead

• Primary Device ID: 00840682102964
• NIH Device Record Key: 4f946fbb-4535-40ec-9fba-b6bed34f666a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entropy
• Version Model Number: Entropy Cable, M1050784
• Company DUNS: 401966697
• Company Name: GE Healthcare Finland Oy
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)558-5120
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682102964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062580

FDA Product Code

• GXY: ELECTRODE, CUTANEOUS

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: 2018-07-06
• Device Publish Date: 2016-06-30

On-Brand Devices [Entropy]

• 20840682102975: EasyFit sensor, M1174413
• 00840682102964: Entropy Cable, M1050784
• 20840682102951: GE Entropy sensor, M1038681