Somnera Nasal Pillow Fit Kit 45603

GUDID 00810045450070

Nasal pillow mask for use with the Somnera Positive Airway Pressure System

FRESCA MEDICAL, INC.

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• Primary Device ID: 00810045450070
• NIH Device Record Key: b3e17f41-c4a7-4bfe-85ff-9a29c0bb657e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Somnera Nasal Pillow Fit Kit
• Version Model Number: P3
• Catalog Number: 45603
• Company DUNS: 068329904
• Company Name: FRESCA MEDICAL, INC.
• Device Count: 10
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com
• Phone: 9495423535
• Email: info@somnera.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810045450070 [Unit of Use]
GS1	30810045450071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200698

FDA Product Code

• QBY: Positive Airway Pressure System

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: 2021-01-05
• Device Publish Date: 2020-12-28

Devices Manufactured by FRESCA MEDICAL, INC.

• 00810045450025 - Somnera Backstrap: 2021-05-17 Somnera Backstrap for use with the Somnera Positive Airway Pressure System
• 00810045450049 - Somnera Pillow: 2021-05-17 Nasal Pillow Mask for use with the Somnera Positive Airway Pressure System
• 00810045450056 - Somnera Pillow: 2021-05-17 Somnera Nasal Pillow for use with the Somnera Positive Airway Pressures System
• 00810045450063 - Somnera Pillow: 2021-05-17 Nasal Pillow for use with the Somnera Positive Airway Pressure System
• 00810045450087 - Somnera Nasal Mask: 2021-05-17 Somnera Nasal Mask for use with the Somnera Positive Airway Pressure System
• 00810045450094 - Somnera Nasa Mask: 2021-05-17 Somnera Nasal Mask for use with the Somnera Positive Airway Pressure System
• 00810045450100 - Somnera Nasal Mask: 2021-05-17 Somnera Nasal Mask for use with the Somnera Positive Airway Pressure System
• 00810045450131 - Somnera Airbox Air Filter Pack: 2021-05-17 Air Filter pack for use with Somnera Airbox Flow Generator