SOMNOscreen

GUDID 04250413400492

SOMNOmedics GmbH

Polysomnograph

• Primary Device ID: 04250413400492
• NIH Device Record Key: 576f949a-a4bb-4eb9-a94c-346d3d6d2426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOMNOscreen
• Version Model Number: SSC050
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250413400492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060708

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: 2016-09-22

Devices Manufactured by SOMNOmedics GmbH

• 04250413405640 - ABPM pro basic device: 2024-05-16
• 04250413402748 - SOMNOwatch plus ACTI: 2023-12-15
• 04250413402755 - SOMNOwatch plus ACTI: 2023-12-15
• 04250413410781 - SOMNO HD / ECO accessory: 2023-12-08
• 04250413410828 - SOMNOscreen ECO EEG 32: 2023-12-08
• 04250413410835 - SOMNOtouch RESP accessory: 2023-12-08
• 04250413410842 - SOMNOtouch RESP accessory: 2023-12-08
• 04250413410859 - SOMNOtouch RESP accessory: 2023-12-08