FDA.reportPublic FDA data

AMEDA®

Primary DI
08809462731307
Brand
AMEDA®
Company
CIMILRE CO .,LTD
Model
102A02
Device description
This is powered breast pump intended to express and collect milk from the breasts of lactating women.The final product is packed in a box with necessary connecting parts including backflow protector, tubing, valves, bottle, power adapter, flanges, locking rings, locking cap, small bag and user manual, so the user can use the device right after receiving them.
Published
2019-01-04
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
HGXPump, Breast, Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809462731307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809462731307088094627313078809462731307

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
1-866-992-6332parentcare@ameda.com

Regulatory Flags#

DUNS number
689851831
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
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
08809462734445Stella Baby USASB2100022024-12-12
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00020451904870Freestyle™ Mini Hands-freeMedela LLCHGX2026-05-01
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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
16973493597993MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493598235MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493598341MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493599362MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
00020451903873Motion InBra™Medela LLCHGX2026-02-16
00020451903880Motion InBra™Medela LLCHGX2026-02-16
08809108019684SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019691SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019707SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019714SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019769SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019776SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019783SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019790SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019820SpectraUZINMEDICARE CO.,LTDHGX2026-02-03