FDA.reportPublic FDA data

Rumble Tuff

Primary DI
10879388001094
Brand
Rumble Tuff
Company
A Cute Baby Inc
Model
200DP
Device description
Rumble Tuff EZ Express Electric Breast Pump
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113315000RUMBLE TUFFAcute Ideas Co. , Ltd.2012-11-20HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10879388001094PackageGS16In Commercial Distribution
00879388001097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087938800109410879388001094
00879388001097008793880010978793880010970879388001097

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, electricA mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-609-8168customerservice@rumbletuff.com

Regulatory Flags#

DUNS number
782208318
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00879388002094Rumble TuffBN3032025-12-03
00879388003633Rumble TuffMT905Q2025-12-03
10853396003622Rumble Tuff209DA22025-12-03
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
07640108055903Breast shell sterile DeTach 12 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055927Breast shell sterile DeTach 13 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055941Breast shell sterile DeTach 14 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055965Breast shell sterile DeTach 15 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)Ardo medical AGHGX2026-07-30
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