Unimom

GUDID 08809224872460

The Opera+ is multiple-user, powered breast pumps intended to help a mother, especially those who have an excess of milk or have difficulty breast-feeding, extract residual milk from her breast

UNIMOM CO.

Breast pump, electric

• Primary Device ID: 08809224872460
• NIH Device Record Key: a7ad84a2-0bb9-452d-b62e-8b2ffb90930f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unimom
• Version Model Number: Opera+
• Company DUNS: 689057658
• Company Name: UNIMOM CO.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: true

Customer Support Contacts

• Phone: +827087985577
• Email: infounimom@naver.com
• Phone: +827087985577
• Email: infounimom@naver.com
• Phone: +827087985577
• Email: infounimom@naver.com
• Phone: +827087985577
• Email: infounimom@naver.com
• Phone: +827087985577
• Email: infounimom@naver.com
• Phone: +827087985577
• Email: infounimom@naver.com
• Phone: +827087985577
• Email: infounimom@naver.com
• Phone: +827087985577
• Email: infounimom@naver.com
• Phone: +827087985577
• Email: infounimom@naver.com
• Phone: +827087985577
• Email: infounimom@naver.com
• Phone: +827087985577
• Email: infounimom@naver.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809224872460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190810

FDA Product Code

• HGX: Pump, Breast, Powered

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: 2021-11-15
• Device Publish Date: 2021-11-05

On-Brand Devices [Unimom]

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• 08809224872422: Unimom accessory(24mm shield set)
• 08809224872415: Unimom accessory(20mm shield set)
• 08809224872408: The Minuet LCD+ is multiple-user, powered breast pumps intended to help a mother, especially tho
• 08809224872460: The Opera+ is multiple-user, powered breast pumps intended to help a mother, especially those wh