FDA.reportPublic FDA data

Electric Breast Pump

Primary DI
06972562618334
Brand
Electric Breast Pump
Company
NINGBO HUIYOO BABY PRODUCTS CO.,LTD
Model
RBX8037
Published
2022-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K191802000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191802000Electric Breast PumpNingbo Huiyoo Baby Products Co., Ltd.2020-01-16HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972562618334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972562618334069725626183346972562618334

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
554457373
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972562618341Electric Breast PumpBLA8040-22022-05-16
06972562618358Electric Breast PumpBLA8042-22022-05-16
06972562618297Electric Breast PumpBLA80402022-04-13
06972562618303Electric Breast PumpBLA80412022-04-13
06972562618310Electric Breast PumpBLA80422022-04-13
06972562618327Electric Breast PumpBLA80432022-04-13
06972562618174Electric Breast PumpRBX80152020-02-28
06972562618181Electric Breast PumpRBX80202020-02-28
06972562618198Electric Breast PumpRBX80212020-02-28
06972562618204Electric Breast PumpRBX80292020-02-28
06972562618211Electric Breast PumpRBX80302020-02-28
06972562618228Electric Breast PumpRBX80282020-02-28
06972562618235Electric Breast PumpRBX80312020-02-28
06972562618242Breast PumpBLA-8017-12020-02-28
06972562618259Breast PumpBLA-80172020-02-28
06972562618266Breast PumpBLA80172020-02-28
06972562618273Breast PumpBLA80122020-02-28
06972562618280Breast PumpBLA80132020-02-28
06972562618013Electric Breast PumpBLA-80152020-02-27
06972562618020Electric Breast PumpBLA-8015-022020-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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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