FDA.reportPublic FDA data

Dr. Brown's

Primary DI
B740BF1001
Brand
Dr. Brown's
Company
Dr. Brown's Company
Model
BF100
Device description
Customflow Double Electric Breast Pump
Published
2020-08-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K192640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192640000Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast PumpGuangzhou Yongyi Industrial Co., Ltd.2020-03-30HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B740BF1001PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
833-224-7675breastpumpsupport@handi-craft.com

Regulatory Flags#

DUNS number
055872634
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
00072239303597Dr. Brown'sSB42002-WEB2026-06-08
00072239303603Dr. Brown'sSB412-MED2026-06-08
00072239303863Dr. Brown'sSB82002-WEB2026-06-08
00072239306130Dr. Brown'sSB812-MED2026-06-08
00072239307274Dr. Brown'sSB05007-WEB2026-06-08
00072239310472Dr. Brown'sSB815-MED2026-06-08
00072239313060Dr. Brown'sSB417-MED2026-06-08
00072239325049Dr. Brown'sSB816-MED2026-06-08
00072239329252Dr. Brown'sAC2802026-06-08
00072239329269Dr. Brown'sAC2812026-06-08
00072239330265Dr. Brown'sWB51100-MED2026-06-08
00072239330272Dr. Brown'sWB91100-MED2026-06-08
00072239330753Dr. Brown'sTE4552026-06-08
00072239331842Dr. Brown'sTE1102026-06-08
00072239331859Dr. Brown'sTE2012026-06-08
00072239331866Dr. Brown'sTE1112026-06-08
00072239331873Dr. Brown'sTE2112026-06-08
00072239331897Dr. Brown'sTE1122026-06-08
00072239332139Dr. Brown'sTE4512026-06-08
00072239332146Dr. Brown'sTE4522026-06-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640108055903Breast shell sterile DeTach 12 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055927Breast shell sterile DeTach 13 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055941Breast shell sterile DeTach 14 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055965Breast shell sterile DeTach 15 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)Ardo medical AGHGX2026-07-30
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06925546003381ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
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