Siesta 9007-0061-01

GUDID 09342451002112

Siesta 802 Basic EEG System w/o Software

COMPUMEDICS USA, INC.

Electroencephalographic ambulatory recorder

• Primary Device ID: 09342451002112
• NIH Device Record Key: 4f58a7b1-a9d1-461a-931c-513a2bdb6358
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Siesta
• Version Model Number: Siesta 802 Basic EEG System
• Catalog Number: 9007-0061-01
• Company DUNS: 111312307
• Company Name: COMPUMEDICS USA, INC.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09342451002112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003175

FDA Product Code

• OLV: Standard Polysomnograph With 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: 2020-12-24
• Device Publish Date: 2020-12-16

On-Brand Devices [Siesta]

• 09342451001788: Siesta 802 Basic PSG System w/o Software
• 09342451002112: Siesta 802 Basic EEG System w/o Software