FDA.reportPublic FDA data

Stella Baby USA

Primary DI
08809462734445
Brand
Stella Baby USA
Company
CIMILRE CO .,LTD
Model
SB210002
Published
2024-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809462734445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809462734445088094627344458809462734445

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-446-6622warranty@Stellababyusa.com

Regulatory Flags#

DUNS number
689851831
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809462734537Stella Baby USASB5500022025-07-04
08809462734605Stella Baby USASB830012-S2025-07-04
08809462734612Stella Baby USASB830032-S2025-07-04
08809462734629Stella Baby USASB350212-S2025-07-04
08809462734636Stella Baby USASB350242-S2025-07-04
08809462734643Stella Baby USASB350282-S2025-07-04
08809462734650Stella Baby USASB550002-S2025-07-04
08809462734483Stella Baby USASB8300122025-07-03
08809462734490Stella Baby USASB8300322025-07-03
08809462734506Stella Baby USASB3502122025-07-03
08809462734513Stella Baby USASB3502422025-07-03
08809462734520Stella Baby USASB3502822025-07-03
08809462734452Stella Baby USASB7100022024-12-12
08809462734469Stella Baby USASB8100022024-12-12
08809462733981Symmetrical Health, LLCCM0A14-192024-02-15
08809462734186Symmetrical Health, LLCS7_DUAL_PRO_S7-100-00-002024-02-15
08809462733974Symmetrical Health, LLCCM0A222024-02-14
08809462734209Motif MedicalAAA0013-282024-02-14
08809462734292Motif MedicalAAA0013-292024-02-14
08809462734391Motif Medical301Z312024-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809444071049HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071056HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071223HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071230HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071339HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071346HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071353HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071360HaenimHaenim Co.,Ltd.HGX2026-06-05
06976313750014AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750021AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750212AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750229AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750236AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750649AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750656AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750663AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
08809108020017SpectraUZINMEDICARE CO.,LTDHGX2026-04-30
08809108020024SpectraUZINMEDICARE CO.,LTDHGX2026-04-30
19551028430006AmedaTPH TECHNOLOGY MALAYSIA SDN. BHD.HGX2026-03-03
07640108054975Ardo MeliaArdo medical AGHGX2026-02-27
08809108019912SpectraUZINMEDICARE CO.,LTDHGX2026-02-27
16973493597344TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493599430TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493592226MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493592431lansinoh Shenzhen TPH Technology Co., LtdHGX2026-02-25
16973493592530MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493593995MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493594244MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493594374MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493597078MommedShenzhen TPH Technology Co., LtdHGX2026-02-25