Baby Buddha

GUDID 00867494000424

Comfort Double Electric

BABYBUDDHA PRODUCTS LLC

Breast pump, electric

• Primary Device ID: 00867494000424
• NIH Device Record Key: 3fe1e0dc-5c82-4094-8eac-bf0dcd91d150
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baby Buddha
• Version Model Number: BB1
• Company DUNS: 076697261
• Company Name: BABYBUDDHA PRODUCTS LLC
• 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: false

Customer Support Contacts

• Phone: 845.893.8747
• Email: joe@babybuddhaproducts.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867494000424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151284

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-08

On-Brand Devices [Baby Buddha]

• 00867494000424: Comfort Double Electric
• 00867494000417: Comfort Double Electric