FDA.reportPublic FDA data

Rumble Tuff

Primary DI
00879388001158
Brand
Rumble Tuff
Company
A Cute Baby Inc
Model
PA91900M
Device description
Rumble Tuff Expression Collection Combo Kits (For Breeze Pro)
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
PWABreast Pump Accessory, Milk Expression Aid, Via Positive Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWABreast Pump Accessory, Milk Expression Aid, Via Positive PressureObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10879388001155PackageGS110In Commercial Distribution
00879388001158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087938800115510879388001155
00879388001158008793880011588793880011580879388001158

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, manualA 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.

Contacts#

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

Regulatory Flags#

DUNS number
782208318
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853396003625Rumble Tuff209DA22025-12-03
00879388001097Rumble Tuff200DP2025-12-03
00879388002094Rumble TuffBN3032025-12-03
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
10879388001155Rumble TuffA Cute Baby IncPWA2025-12-03
09420060203028Ladybug Silicone Breast Milk Collector - 150mlTHINK GREEN LIMITEDPWA2024-12-18
09420060203035Ladybug Silicone Breast Milk Collectors (150ml) - 2pcsTHINK GREEN LIMITEDPWA2024-12-18
09420060203042Ladybug Silicone Breast Milk Collectors (75ml) - 2pcsTHINK GREEN LIMITEDPWA2024-12-18
09420060203011Ladybug Silicone Breast Milk Collector - 75mlTHINK GREEN LIMITEDPWA2024-12-17
09420060203059Ladybug Silicone Breast Milk Collectors (40ml) - 2pcsTHINK GREEN LIMITEDPWA2024-12-17
09420060203066Ladybug Silicone Breast Milk Collector - 40mlTHINK GREEN LIMITEDPWA2024-12-17
09420060204018Silicone Colostrum Collector (pre-sterilised) - 1pcTHINK GREEN LIMITEDPWA2024-12-17
09420060204025Silicone Colostrum Collector (pre-sterilised) - 2pcsTHINK GREEN LIMITEDPWA2024-12-17
09420060204032Silicone Colostrum Collector (pre-sterilised) - 20ml - 1pcTHINK GREEN LIMITEDPWA2024-12-17
09420060204049Silicone Colostrum Collector (pre-sterilised) - 20ml - 2pcsTHINK GREEN LIMITEDPWA2024-12-17
09420060204056Silicone Colostrum Collector Pack (pre-sterilised) - 6pcsTHINK GREEN LIMITEDPWA2024-12-17
09420060204063Silicone Colostrum Collector Pack (pre-sterilised) - 12pcsTHINK GREEN LIMITEDPWA2024-12-17
09420060204070Multi-size Silicone Colostrum Collector Pack (pre-sterilised) - 20ml*1+4ml*4THINK GREEN LIMITEDPWA2024-12-17
19420060204084Silicone Colostrum Collector 50pc Bulk Pack (pre-sterilised) THINK GREEN LIMITEDPWA2024-12-17
00735282381843MunchkinMUNCHKIN, INC.PWA2024-08-01
00735282383946MunchkinMUNCHKIN, INC.PWA2024-08-01
10735282381840MunchkinMUNCHKIN, INC.PWA2024-08-01
10735282383943MunchkinMUNCHKIN, INC.PWA2024-08-01
05060442521759Elvie Nipple CushionWILLOW INNOVATIONS, INC.PWA2023-05-25
05060442521766Elvie Nipple CushionWILLOW INNOVATIONS, INC.PWA2023-05-25
05060442521773Elvie Nipple CushionsWILLOW INNOVATIONS, INC.PWA2023-05-25
00850004882702Nurture BraIMALAC, INC.PWA2019-11-19
00850004882719Nurture BraIMALAC, INC.PWA2019-11-19
00850004882016Nurture ControllerIMALAC, INC.PWA2019-10-31
00850004882023Nurture Power SupplyIMALAC, INC.PWA2019-10-31
00850004882030Nurture Battery PackIMALAC, INC.PWA2019-10-31
00850004882047Nurture Compression PadIMALAC, INC.PWA2019-10-31
00850004882054Nurture Compression PadIMALAC, INC.PWA2019-10-31
00850004882061Nurture Compression PadIMALAC, INC.PWA2019-10-31