COMBY EEG CAP BFRA

GUDID 03858894154135

Chest belt for EEG cap for adults

PAMEL d.o.o.

Analytical scalp electrode, reusable

• Primary Device ID: 03858894154135
• NIH Device Record Key: 195fd399-d50d-4275-96a3-944fe440c6f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMBY EEG CAP
• Version Model Number: Chest belt for EEG cap for adults
• Catalog Number: BFRA
• Company DUNS: 643949162
• Company Name: PAMEL d.o.o.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	03858894154135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211315

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2023-08-24
• Device Publish Date: 2023-08-16

On-Brand Devices [COMBY EEG CAP]

• 03858894153183: Electrode CUP with 120cm lead wire and sintered Ag/AgCl electrode
• 03858894151974: Comby EEG cap with 22 Ag/AgCl electrodes, size 57-62
• 03858894151967: Comby EEG cap with 22 Ag/AgCl sintered electrodes, size 52-57
• 03858894151950: Comby EEG cap with 22 Ag/AgCl sintered electrodes, size 47-52
• 03858894154135: Chest belt for EEG cap for adults
• 03858894153442: Bypass electrodes Ag/AgCl, yellow
• 03858894153428: Bypass electrodes Ag/AgCl, red
• 03858894153411: Bypass electrodes Ag/AgCl, green
• 03858894153398: Bypass electrodes Ag/AgCl
• 03858894152834: Comby EEG cap with 34 Ag/AgCl sintered electrodes, size 57-62
• 03858894152827: Comby EEG cap with 34 Ag/AgCl sintered electrodes, size 52-57
• 03858894152810: Comby EEG cap with 34 Ag/AgCl sintered electrodes, size 47-52