HORIGEN

GUDID 00694065790206

Guangdong Horigen Mother & Baby Products Co., Ltd.

Breast pump, electric

• Primary Device ID: 00694065790206
• NIH Device Record Key: 634a6c6c-a40e-4ad1-b3c2-39ee67ed8d0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HORIGEN
• Version Model Number: XN-2219M1
• Company DUNS: 529354502
• Company Name: Guangdong Horigen Mother & Baby Products Co., Ltd.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00694065790206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143585

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: 2024-09-19
• Device Publish Date: 2023-07-13

On-Brand Devices [HORIGEN]

• 36940657922049: single electric breast pump
• 36940657922032: single electric breast pump
• 06940657902033: XN-2219M2
• 06940657902019: XN-2212M2
• 00694065790206: XN-2219M1