FDA.reportPublic FDA data

TPH

Primary DI
26973493599437
Brand
TPH
Company
Shenzhen TPH Technology Co., Ltd
Model
S12A
Published
2026-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K243508000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243508000Wearable breast pump (model S12A)Shenzhen TPH Technology Co., Ltd.2025-04-21HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26973493599437PackageGS132In Commercial Distribution
16973493599430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697349359943726973493599437
1697349359943016973493599430

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

Regulatory Flags#

DUNS number
403304567
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
16973493597344TPHS1dw2026-02-27
16973493599430TPHS12A2026-02-27
26973493597341TPHS1dw2026-02-27
16973493592226MommedS332026-02-25
16973493592431lansinoh P32026-02-25
16973493592530MommedS332026-02-25
16973493593995MommedS332026-02-25
16973493594244MommedS332026-02-25
16973493594374MommedS332026-02-25
16973493597078MommedS332026-02-25
16973493597993MommedS332026-02-25
16973493598235MommedS332026-02-25
16973493598341MommedS332026-02-25
16973493599362MommedS332026-02-25
06973493598412AmedaW8S2026-02-25
16973493598419AmedaW8S2026-02-25
26973493592223MommedS332026-02-25
26973493592438lansinoh P32026-02-25
26973493592537MommedS332026-02-25
26973493593992MommedS332026-02-25

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