GD EIM-107-25B

GUDID 00086186000331

The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 25 Lead EEG with 25 Pin Female "D" Connector (All 25 Pins Wired) .

General Devices

Electrocardiographic electrode tester

• Primary Device ID: 00086186000331
• NIH Device Record Key: 84907577-a024-4129-b1c2-89f436414fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GD
• Version Model Number: Prep-Check Plus, 25 pin
• Catalog Number: EIM-107-25B
• Company DUNS: 101394815
• Company Name: General Devices
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00086186000331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993202

FDA Product Code

• GZO: Device, Galvanic Skin Response Measurement

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: 2016-09-23

On-Brand Devices [GD]

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• 00862186000324: The Prep-Check Plus, 20 pin model is a hand-held, battery powered device intended to measure the
• 00862186000317: The Prep-Check 30Hz is a hand-held, battery powered device intended to measure the electrical im
• 00862186000300: The Prep-Check 10Hz is a hand-held, battery powered device intended to measure the electrical im
• 00862186000331: The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the elect