FDA.reportPublic FDA data

Bellema

Primary DI
06940657922062
Brand
Bellema
Company
Guangdong Horigen Mother & Baby Products Co., Ltd.
Model
XN-2208H2
Device description
double electric breast pump
Published
2017-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

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
26940657922066PackageGS16In Commercial Distribution
06940657922062PrimaryGS10
11171630210001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2694065792206626940657922066
06940657922062069406579220626940657922062
1117163021000111171630210001

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529354502
Device count
1000
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00694065790206HORIGENXN-2219M12023-07-13
06940657902019HORIGENXN-2212M22023-10-10
06940657902033HORIGENXN-2219M22023-10-10
00810115233718femometerXN/MD-2267R2023-10-10
00810115233763femometerXN/MD-2267R2023-10-10
06940657921003BellemaXN-2203H22017-12-23
06940657921010BellemaXN-2203H42016-12-24
06940657922024babystepsXN-2206M22017-12-23
06940657922031HORIGENXN-2207M12017-12-23
06940657922048HORIGENXN-2209M12017-12-23
06940657922055BellemaXN-2210M22016-12-24
06940657966653BellemaXN-2301SY2017-12-23
06940657966714BellemaXN-2306SY2017-12-23
36940657921004BellemaXN-2203H22017-12-23
36940657921011BellemaXN-2203H42016-12-24
06940657922000BellemaXN-2201M12017-12-23
06940657922017BellemaXN-2201M32017-12-23
26940657922028babystepsXN-2206M22017-12-23
36940657922032HORIGENXN-2207M12017-12-23
36940657922049HORIGENXN-2209M12017-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809444071223HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071230HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071339HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071346HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071353HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071360HaenimHaenim Co.,Ltd.HGX2026-06-05
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06976313750663AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
08809108020017SpectraUZINMEDICARE CO.,LTDHGX2026-04-30
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19551028430006AmedaTPH TECHNOLOGY MALAYSIA SDN. BHD.HGX2026-03-03
07640108054975Ardo MeliaArdo medical AGHGX2026-02-27
08809108019912SpectraUZINMEDICARE CO.,LTDHGX2026-02-27
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16973493594374MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493597078MommedShenzhen TPH Technology Co., LtdHGX2026-02-25