hygeia

GUDID 08809462731925

CIMILRE CO .,LTD

Breast pump, electric

• Primary Device ID: 08809462731925
• NIH Device Record Key: 01ad19d7-d070-444b-b50d-1075872b1d2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hygeia
• Version Model Number: 30-0122
• Company DUNS: 689851831
• Company Name: CIMILRE CO .,LTD
• Device Count: 1
• DM Exempt: true
• 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: 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: 714-515-7571
• Email: jmurdock@hygeiababy.com
• Phone: 714-515-7571
• Email: jmurdock@hygeiababy.com
• Phone: 714-515-7571
• Email: jmurdock@hygeiababy.com
• Phone: 714-515-7571
• Email: jmurdock@hygeiababy.com
• Phone: 714-515-7571
• Email: jmurdock@hygeiababy.com
• Phone: 714-515-7571
• Email: jmurdock@hygeiababy.com
• Phone: 714-515-7571
• Email: jmurdock@hygeiababy.com
• Phone: 714-515-7571
• Email: jmurdock@hygeiababy.com
• Phone: 714-515-7571
• Email: jmurdock@hygeiababy.com
• Phone: 714-515-7571
• Email: jmurdock@hygeiababy.com
• Phone: 714-515-7571
• Email: jmurdock@hygeiababy.com
• Phone: 714-515-7571
• Email: jmurdock@hygeiababy.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809462731925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162870

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: 2019-09-27
• Device Publish Date: 2019-09-19

On-Brand Devices [hygeia]

• 08809462732007: 20-0085
• 08809462731994: 30-0131
• 08809462731987: 30-0130
• 08809462731970: 30-0129
• 08809462731963: 30-0128
• 08809462731956: 30-0125
• 08809462731949: 30-0124
• 08809462731932: 30-0123
• 08809462731925: 30-0122
• 08809462731918: 20-0111
• 08809462731901: 40-0044
• 08809462731895: 10-0168
• 08809462732526: 30-0134
• 08809462732519: 30-0133