Entropy

GUDID 20840682102951

GE Healthcare Finland Oy

Analytical scalp electrode, single-use

• Primary Device ID: 20840682102951
• NIH Device Record Key: c95a4d5c-1434-43a9-8646-0487d9a52b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entropy
• Version Model Number: GE Entropy sensor, M1038681
• 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: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682102957 [Primary]
GS1	20840682102951 [Package]; Contains: 00840682102957; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082540

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: 2016-08-15

On-Brand Devices [Entropy]

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