Perifit Pump

GUDID 03770014642271

X6 INNOVATIONS

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• Primary Device ID: 03770014642271
• NIH Device Record Key: 0edfd960-e08f-4830-80e6-17b35560fdc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perifit Pump
• Version Model Number: Perifit Pump 24mm
• Company DUNS: 264648644
• Company Name: X6 INNOVATIONS
• 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	03770014642271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231785

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: 2024-03-18
• Device Publish Date: 2024-03-08

On-Brand Devices [Perifit Pump]

• 03770014642295: Perifit Pump 18mm
• 03770014642288: Perifit Pump 27mm
• 03770014642271: Perifit Pump 24mm
• 03770014642264: Perifit Pump 21mm
• 03770014642233: Perifit Pump 15mm