SpO2 Soft Silicone Finger Clip

GUDID 04250413401796

SOMNOmedics GmbH

Polysomnograph

• Primary Device ID: 04250413401796
• NIH Device Record Key: 8cefcd1f-3c7a-436a-8b85-ad8cf664fb49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpO2 Soft Silicone Finger Clip
• Version Model Number: SEWP150
• 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	04250413401796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071556

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: 2019-04-22
• Device Publish Date: 2019-04-12

Devices Manufactured by SOMNOmedics GmbH

• 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
• 04250413400522 - SOMNOscreen Plus accessory: 2023-09-04