Seer Home

GUDID 09355751001235

Seer App: Epilepsy Management

SEER MEDICAL HOLDINGS LIMITED

Electroencephalograph

• Primary Device ID: 09355751001235
• NIH Device Record Key: 96ff355c-09a4-4cd7-81eb-e629b033345f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Seer Home
• Version Model Number: Seer App: Epilepsy Management
• Company DUNS: 744473197
• Company Name: SEER MEDICAL HOLDINGS LIMITED
• 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: 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	09355751001235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212788

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-05
• Device Publish Date: 2024-06-27

On-Brand Devices [Seer Home]

• 09355751001129: Disposable EEG Wires
• 09355751001051: Seer App: Epilepsy Management
• 09355751001044: Seer Cloud
• 09355751001020: Sense
• 09355751001136: Monitoring Portal
• 09355751001112: WaterTabs Application Kit
• 09355751001099: Take-home Kit
• 09355751001105: WaterTabs Pack
• 09355751001037: Sight
• 09355751001266: WaterTabs Application Kit
• 09355751001273: WaterTabs Pack
• 09355751001242: Seer Cloud
• 09355751001235: Seer App: Epilepsy Management
• 09355751001228: Monitoring Portal
• 19355751001218: Disposable EEG Wires
• 09355751001181: Sight
• 09355751001174: Sense