Rumble Tuff

Basic Information

• Brand Name: Rumble Tuff
• Primary DI: 00879388001158
• Version / Model: PA91900M
• Company Name: A Cute Baby Inc
• Labeler DUNS: 782208318
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-03
• Public Version: 2
• Public Version Date: 2025-12-11
• Public Version Status: Update
• Public Device Record Key: c09b8607-cba1-4aa4-a675-afd3d9d57b04

Device Description

Rumble Tuff Expression Collection Combo Kits (For Breeze Pro)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PWA	Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	Obstetrics/Gynecology	884.5150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38477	Breast pump, manual	A hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10879388001155	GS1	Case	10	In Commercial Distribution
Primary	00879388001158	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]