FDA.reportPublic FDA data

PURE ENRICHMENT

Primary DI
B311PEBRPUMP0
Brand
PURE ENRICHMENT
Company
BEAR DOWN CONSULTING
Model
PEBRPUMP
Device description
Dual electric breast pump.
Published
2018-12-03
Public version status
Update
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
K151284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151284000Electric Double Breast PumpsWuxi Xinzhongrui Baby Supplies Co., Ltd.2015-12-21HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B311PEBRPUMP1PackageHIBCC12In Commercial Distribution
B311PEBRPUMP0PrimaryHIBCC0

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
040869867
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853975005675Pure EnrichmentPEGELPAK2023-04-07
00810115635185Pure EnrichmentPEHUTRB2G-W2025-09-08
B311PEPULSERT0PURE ENRICHMENTPEPULSE-RT2022-07-22
00810115633235VeriluxVT54WW62024-10-07
00768533810007VeriluxVT20WW12024-09-22
00810115633280Pure EnrichmentPEHPWD2-PE2024-08-28
B311PETNHTPR0PURE ENRICHMENTPETNHTPR2023-12-15
B311PETNHTPR1PURE ENRICHMENTPETNHTPR2023-12-15
B311PEHTNPDS20PURE ENRICHMENTPEHTNPDS22023-12-14
B311PEHTNPDS50PURE ENRICHMENTPEHTNPDS52023-12-14
B311PEHTNPDS21PURE ENRICHMENTPEHTNPDS22023-12-14
B311PEHTNPDS51PURE ENRICHMENTPEHTNPDS52023-12-14
00768533140043VeriluxVT32WW32023-05-17
00768533140050VeriluxVT31WW32023-05-17
00768533140067VeriluxVT43WW32023-05-17
00768533140098VeriluxVT42WW32023-05-17
00768533140104VeriluxVT52WW32023-05-17
00817387024228VeriluxVT37WW12023-05-17
00817387025799VeriluxVT43MB32023-05-17
00817387025805VeriluxVT43CG32023-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
08809108019684SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019691SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019707SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019714SpectraUZINMEDICARE CO.,LTDHGX2026-02-03