Onera STS ONERA STS1 HEAD

GUDID 08720256698005

Onera B.V.

Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser

• Primary Device ID: 08720256698005
• NIH Device Record Key: 32a0509e-5079-4d1b-9aec-26362f1b5bfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Onera STS
• Version Model Number: 01.00
• Catalog Number: ONERA STS1 HEAD
• Company DUNS: 492293557
• Company Name: Onera B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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 Dimensions

• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter
• Weight: 34 Gram
• Height: 26 Millimeter
• Length: 60 Millimeter
• Width: 46 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08720256698005 [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