FDA.reportPublic FDA data

lansinoh

Primary DI
06973493596494
Brand
lansinoh
Company
Shenzhen TPH Technology Co., Ltd
Model
S32-D
Published
2023-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K223886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223886000Wearable Breast Pump (Model S18)Shenzhen TPH Technology Co., Ltd.2023-07-14HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973493593766PackageGS18In Commercial Distribution
06973493596494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697349359376616973493593766
06973493596494069734935964946973493596494

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.

Regulatory Flags#

DUNS number
403304567
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973493598863MotifS37-D2025-07-23
26973493590991Figaroo™ElevateS392026-06-22
26973493592834Figaroo™ EaseFS12A2026-06-22
16973493597344TPHS1dw2026-02-27
16973493599430TPHS12A2026-02-27
26973493597341TPHS1dw2026-02-27
26973493599437TPHS12A2026-02-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937266900017FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900024FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900031FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900048FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900055FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900062FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900079FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900086FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900093FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900109FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900116FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900123FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900130FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
00020451906065Pump In Style Pro+ w/HarmonyMedela LLCHGX2026-07-20
00810104131018Willow Sync 5oz Container SetWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131025Willow Sync Container Back ReplacementWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131032Willow Sync Duckbill ValvesWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131049Willow Sync DiaphragmsWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131056Willow Sync 24mm FlangesWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131063Willow Sync Tubing AssemblyWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131087Willow Sync Receiver ReplacementWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131094Willow Sync Replacement PumpWILLOW INNOVATIONS, INC.HGX2026-07-16
00879388005132Rumble TuffA Cute Baby IncHGX2026-07-05
06935883910013Figaroo™ GoFlowHuizhou LVB Maternal & Infant Supplies Co., Ltd.HGX2026-07-03
06951727603019Figaroo™ EnduraShenzhen Changkun Technology Co., Ltd.HGX2026-06-26
06951727603033Figaroo™ DashShenzhen Changkun Technology Co., Ltd.HGX2026-06-26
26973493590991Figaroo™ElevateShenzhen TPH Technology Co., LtdHGX2026-06-22
26973493592834Figaroo™ EaseShenzhen TPH Technology Co., LtdHGX2026-06-22
08809444071049HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071056HaenimHaenim Co.,Ltd.HGX2026-06-05