SOMNOscreen plus Accessory

GUDID 00833166000405

SOMNOmedics GmbH

Polysomnograph

• Primary Device ID: 00833166000405
• NIH Device Record Key: d19f3d97-0194-4871-82d0-7f45fcb13ff2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOMNOscreen plus Accessory
• Version Model Number: SEN209
• Company DUNS: 314112173
• Company Name: SOMNOmedics GmbH
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00833166000405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081485

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2017-05-22

On-Brand Devices [SOMNOscreen plus Accessory]

• 04250413400560: SEN599T
• 04250413400430: SEN635
• 04250413400409: SEN624
• 04250413400379: SEN603
• 04250413400348: SEN600T
• 04250413400218: SEN633
• 00833166000412: SEN215
• 00833166000405: SEN209
• 04250413400614: SEN614
• 04250413400607: SEN613
• 04250413400522: SEN614O