SOMNOwatch plus ACTI

GUDID 04250413402755

SOMNOmedics GmbH

Wearable multiple physiological parameter recorder, reusable

• Primary Device ID: 04250413402755
• NIH Device Record Key: 3d98f0da-4dd1-41c1-9769-9897dd96048d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOMNOwatch plus ACTI
• Version Model Number: SOWP200Z
• 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	04250413402755 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-15
• Device Publish Date: 2023-12-07

On-Brand Devices [SOMNOwatch plus ACTI]

• 04250413401475: SOWP200
• 04250413402755: SOWP200Z
• 04250413402748: SOWP100Z