Onera STS ONERA STS1 HEAD CRADLE

GUDID 08720256698029

Onera B.V.

Polysomnography analyser

• Primary Device ID: 08720256698029
• NIH Device Record Key: a0003c4e-60dd-46e0-8925-46ecfad897ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Onera STS
• Version Model Number: 01.00
• Catalog Number: ONERA STS1 HEAD CRADLE
• 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: 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: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com
• Phone: +31403082177
• Email: info@onerahealth.com

Device Dimensions

• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 Millimeter
• Weight: 293 Gram
• Length: 160 Millimeter
• Width: 80 Millimeter
• Height: 86 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	08720256698029 [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