Rumble Tuff

GUDID 10853396003622

Rumble Tuff Breeze Electric Breast Pump

A Cute Baby Inc

Breast pump, electric

• Primary Device ID: 10853396003622
• NIH Device Record Key: 2a9c496c-f3a0-408c-8a98-90ae18a09a4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rumble Tuff
• Version Model Number: 209DA2
• Company DUNS: 782208318
• Company Name: A Cute Baby 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 801-609-8168
• Email: customerservice@rumbletuff.com
• Phone: 801-609-8168
• Email: customerservice@rumbletuff.com
• Phone: 801-609-8168
• Email: customerservice@rumbletuff.com
• Phone: 801-609-8168
• Email: customerservice@rumbletuff.com
• Phone: 801-609-8168
• Email: customerservice@rumbletuff.com
• Phone: 801-609-8168
• Email: customerservice@rumbletuff.com
• Phone: 801-609-8168
• Email: customerservice@rumbletuff.com
• Phone: 801-609-8168
• Email: customerservice@rumbletuff.com
• Phone: 801-609-8168
• Email: customerservice@rumbletuff.com
• Phone: 801-609-8168
• Email: customerservice@rumbletuff.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853396003625 [Primary]
GS1	10853396003622 [Package]; Contains: 00853396003625; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113315

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: 2025-12-11
• Device Publish Date: 2025-12-03

On-Brand Devices [Rumble Tuff]

• 00853396003533: Rumble Tuff Easy Express 2 Electric Breast Pump Duo PA200DA
• 10879388003630: Rumble Tuff Flex-Tip Digital Thermometer
• 00879388002889: Rumble Tuff Whisper Electric Breast Pump
• 10879388002091: Rumble Tuff Baby Nasal Aspirator
• 00879388001165: Rumble Tuff Breeze Pro Electric Breast Pump (Multi-User)
• 10879388001155: Rumble Tuff Expression Collection Combo Kits (For Breeze Pro)
• 10879388001094: Rumble Tuff EZ Express Electric Breast Pump
• 10853396003622: Rumble Tuff Breeze Electric Breast Pump