Rumble Tuff

Basic Information

• Brand Name: Rumble Tuff
• Primary DI: 00879388002094
• Version / Model: BN303
• 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: 578d1942-b202-4ba9-af73-2955ad539782

Device Description

Rumble Tuff Baby Nasal Aspirator

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: Yes
• 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
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	878.4680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41826	Nasal aspirator, manual	A portable, hand-held, manual suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It is available in a variety of forms including a compressible bulb with a tube that is inserted into the nares, or a syringe with a small bulb at its distal end that is applied to the nasal opening. It is designed for domestic use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10879388002091	GS1	Inner Pack	12	In Commercial Distribution
Primary	00879388002094	GS1
Package	20879388002098	GS1	Case	4	In Commercial Distribution

Customer Contacts

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