1 channel ECG sensor including body position and disposable electrodes

GUDID 04250413410712

SOMNOmedics AG

Polysomnograph

• Primary Device ID: 04250413410712
• NIH Device Record Key: 83074052-47b5-438b-929c-b6feeae152be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1 channel ECG sensor including body position and disposable electrodes
• Version Model Number: NGS091S
• Company DUNS: 314112173
• Company Name: SOMNOmedics AG
• 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	04250413410712 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-02-10
• Device Publish Date: 2019-08-13

Devices Manufactured by SOMNOmedics AG

• 04250413410705 - Set for wireless PLM measurement: 2025-02-10
• 04250413410712 - 1 channel ECG sensor including body position and disposable electrodes: 2025-02-10
• 04250413410712 - 1 channel ECG sensor including body position and disposable electrodes: 2025-02-10