FDA.reportPublic FDA data

Rumble Tuff

Primary DI
00879388002094
Brand
Rumble Tuff
Company
A Cute Baby Inc
Model
BN303
Device description
Rumble Tuff Baby Nasal Aspirator
Published
2025-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10879388002091PackageGS112In Commercial Distribution
20879388002098PackageGS14In Commercial Distribution
00879388002094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087938800209110879388002091
2087938800209820879388002098
00879388002094008793880020948793880020940879388002094

GMDN Terms#

Term, Definition table
TermDefinition
Nasal aspirator, manualA 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.

Contacts#

Phone, Email table
PhoneEmail
8552288388customerservice@rumbletuff.com

Regulatory Flags#

DUNS number
782208318
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00879388005132Rumble Tuff208DU32026-07-05
00853396003625Rumble Tuff209DA22025-12-03
00879388001097Rumble Tuff200DP2025-12-03
00879388001158Rumble TuffPA91900M2025-12-03
00879388003633Rumble TuffMT905Q2025-12-03
10853396003622Rumble Tuff209DA22025-12-03
10879388001094Rumble Tuff200DP2025-12-03
10879388001155Rumble TuffPA91900M2025-12-03
00879388001165Rumble TuffPA209DM2025-12-03
10879388002091Rumble TuffBN3032025-12-03
00879388002889Rumble Tuff208DU22025-12-03
10879388003630Rumble TuffMT905Q2025-12-03
00853396003533Rumble TuffPA200DA2019-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04710969717906Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mL, with Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717913Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717920Uresil Evolution Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159787Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159794Uresil Evolution PRE-VAC WOUND DRAINAGE BOTTLECanadian Hospital Specialties LimitedGCY2026-08-18
04719899159824Uresil Evolution Connecting Tube, with SpikeCanadian Hospital Specialties LimitedGCY2026-08-18
10198956231788CARDINAL HEALTHCardinal Health 200, LLCGCY2025-10-20
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
50192253042748ArgyleCardinal Health 200, LLCGCY2025-10-02
50192253042755ArgyleCardinal Health 200, LLCGCY2025-10-02
10198956012769CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
10197106675588CARDINAL HEALTHCardinal Health 200, LLCGCY2024-05-22
10197106600788CARDINAL HEALTHCardinal Health 200, LLCGCY2024-03-25
00630094061504Bioseal Inc.BIOSEALGCY2024-01-29
00630094061511Bioseal Inc.BIOSEALGCY2024-01-29
00630094061528Bioseal Inc.BIOSEALGCY2024-01-29
00630094049175Bioseal Inc.BIOSEALGCY2024-01-25
10197106520932CARDINAL HEALTHCardinal Health 200, LLCGCY2024-01-24
00630094049052Bioseal Inc.BIOSEALGCY2024-01-24
00630094049168Bioseal Inc.BIOSEALGCY2024-01-24
00630094043807Bioseal Inc.BIOSEALGCY2024-01-19
00630094043814Bioseal Inc.BIOSEALGCY2024-01-19
00630094192222Bioseal Inc.BIOSEALGCY2023-12-07
00630094196800Bioseal Inc.BIOSEALGCY2023-11-29
00630094196817Bioseal Inc.BIOSEALGCY2023-11-29
00630094196824Bioseal Inc.BIOSEALGCY2023-11-29
00630094196831Bioseal Inc.BIOSEALGCY2023-11-29
00630094196855Bioseal Inc.BIOSEALGCY2023-11-29
00630094196862Bioseal Inc.BIOSEALGCY2023-11-29
00630094196879Bioseal Inc.BIOSEALGCY2023-11-29