Onera STS ONERA STS1 STATION SOFTWARE

GUDID 08720256698197

Onera B.V.

Polysomnography analyser

• Primary Device ID: 08720256698197
• NIH Device Record Key: 38c3e00b-e384-49ce-9f74-0299fe566652
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Onera STS
• Version Model Number: 01.00
• Catalog Number: ONERA STS1 STATION SOFTWARE
• Company DUNS: 492293557
• Company Name: Onera B.V.
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com
• Phone: +310403082177
• Email: info@onerahealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08720256698197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210593

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: 2023-03-23
• Device Publish Date: 2023-03-15

On-Brand Devices [Onera STS]

• 08720256698197: 01.00
• 08720256698173: 01.00
• 08720256698159: 01.00
• 08720256698135: 01.00
• 08720256698111: 01.00
• 08720256698098: 01.00
• 08720256698074: 01.00
• 08720256698067: 01.00
• 08720256698050: 01.00
• 08720256698043: 01.00
• 08720256698036: 01.00
• 08720256698029: 01.00
• 08720256698012: 01.00
• 08720256698005: 01.00