Evolve Breast Pump

GUDID 00865278000462

A hospital grade double electric breast pump, powered by AC or battery power, used to extract milk from a mother’s breast. The milk will be collected and used to feed infants. The device permits a user to vary the suction strength, and with the use of accessory parts to collect and funnel the breast milk into storage containers. The device utilizes protective measures to prevent the build-up of excessive negative pressure.

HYGEIA II MEDICAL GROUP INC

Breast pump, electric

• Primary Device ID: 00865278000462
• NIH Device Record Key: b2b7f7d3-feeb-4018-a4e7-4c7f8322e104
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evolve Breast Pump
• Version Model Number: 10-0150
• Company DUNS: 033147467
• Company Name: HYGEIA II MEDICAL GROUP INC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865278000462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081932

FDA Product Code

• HGX: Pump, Breast, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-06
• Device Publish Date: 2018-07-05

On-Brand Devices [Evolve Breast Pump]

• 00865278000479: A hospital grade double electric breast pump, powered by AC or battery power, used to extract mi
• 00865278000462: A hospital grade double electric breast pump, powered by AC or battery power, used to extract mi
• 00860001425284: Evolve Breast Pump, pump & Power Supply
• 00860001425277: Evolve Breast Pump, pump & Power Supply
• 00860001425253: Evolve Cordless Breast pump, PAS, Power supply
• 00860001425246: Evolve Cordless Breast pump, and Power supply