Evolve

GUDID 00860001425260

Evolve Breast Pump, pump only

HYGEIA II MEDICAL GROUP INC

Breast pump, electric

• Primary Device ID: 00860001425260
• NIH Device Record Key: b0afb892-9130-4b34-9cde-903f4658fadd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evolve
• Version Model Number: 10-0165
• 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	00860001425260 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-01
• Device Publish Date: 2019-06-21

On-Brand Devices [Evolve]

• 00860001425260: Evolve Breast Pump, pump only
• 00860001425239: Evolve Cordless Breast Pump, only pump