FDA.reportPublic FDA data

Bellema

Primary DI
06940657921003
Brand
Bellema
Company
Guangdong Horigen Mother & Baby Products Co., Ltd.
Model
XN-2203H2
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
36940657921004PackageGS112In Commercial Distribution
06940657921003PrimaryGS10
11161105210001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3694065792100436940657921004
06940657921003069406579210036940657921003
1116110521000111161105210001

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
2000
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
06940657921010BellemaXN-2203H42016-12-24
06940657922024babystepsXN-2206M22017-12-23
06940657922031HORIGENXN-2207M12017-12-23
06940657922048HORIGENXN-2209M12017-12-23
06940657922055BellemaXN-2210M22016-12-24
06940657922062BellemaXN-2208H22017-12-23
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

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Primary DI, Brand, Company table
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