FDA.reportPublic FDA data

Pure Enrichment PureBaby

Primary DI
00817387020787
Brand
Pure Enrichment PureBaby
Company
BEAR DOWN CONSULTING
Model
PEBRPUMP
Published
2019-11-22
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817387020787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817387020787008173870207878173870207870817387020787

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
040869867
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
00810115635185Pure EnrichmentPEHUTRB2G-W2025-09-08
00810115633235VeriluxVT54WW62024-10-07
00768533810007VeriluxVT20WW12024-09-22
00810115633280Pure EnrichmentPEHPWD2-PE2024-08-28
B311PETNHTPR1PURE ENRICHMENTPETNHTPR2023-12-15
B311PEHTNPDS21PURE ENRICHMENTPEHTNPDS22023-12-14
B311PEHTNPDS51PURE ENRICHMENTPEHTNPDS52023-12-14
00810115631521Pure EnrichmentPEHPRDBK-GS2023-07-21
00810115631538Pure EnrichmentPEFIRBK-IG2023-07-21
00810115631545Pure EnrichmentPEFIRNK-IG2023-07-21
00810115631552Pure EnrichmentPEFIRGT-IG2023-07-21
00810115631477Pure EnrichmentPEHUTRB-BDL2023-06-30
00810115631484Pure EnrichmentPEHUTRB-BDL2P2023-06-30
00817387027960Pure EnrichmentPEHPAD24-CAG2023-05-22
00817387028004Pure EnrichmentPEHPVAL-CAG2023-05-22
00817387028011Pure EnrichmentPEHPWIDE-CA2023-05-22
00817387029162Pure EnrichmentPECAHP24-G2023-05-22
00817387029179Pure EnrichmentPECAIR24-G2023-05-22
00768533140043VeriluxVT32WW32023-05-17
00768533140050VeriluxVT31WW32023-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04897152760045eufy Wearable Breast Pump S1 ProAnker Innovations LimitedHGX2026-03-14
04897152760052eufy Wearable Breast Pump E10Anker Innovations LimitedHGX2026-03-14
04897152760069eufy Wearable Breast Pump E20Anker Innovations LimitedHGX2026-03-14
04897152760038eufy Wearable Breast Pump S1Anker Innovations LimitedHGX2026-03-13
39551028430000AmedaTPH TECHNOLOGY MALAYSIA SDN. BHD.HGX2026-03-03
07640108054982Ardo MeliaArdo medical AGHGX2026-02-27
28809108019916SpectraUZINMEDICARE CO.,LTDHGX2026-02-27
26973493597341TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
26973493599437TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493598419AmedaShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592223MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592438lansinoh Shenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592537MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493593992MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493594241MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493594371MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493597075MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493597990MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493598232MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493598348MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493599369MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
00020451904566Motion InBra™Medela LLCHGX2026-02-16
00020451904573Motion InBra™Medela LLCHGX2026-02-16
00850083182007MamaproInterfocus Inc.HGX2026-02-13
00810178887170ViveVIVE HEALTH LLCHGX2026-02-09
28809108019688SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019695SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019701SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019718SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019763SpectraUZINMEDICARE CO.,LTDHGX2026-02-03