FDA.reportPublic FDA data

Motif Medical

Primary DI
08809462732601
Brand
Motif Medical
Company
CIMILRE CO .,LTD
Model
AAA0013-09
Published
2020-09-16
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162870000CIMLRE F1 and CIMILRE S3Cimilre Co., Ltd.2017-03-07HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809462732601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809462732601088094627326018809462732601

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
1-844-272-8390info@motifmedical.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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00020451904870Freestyle™ Mini Hands-freeMedela LLCHGX2026-05-01
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
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