FDA.reportPublic FDA data

Bellema

Primary DI
06940657966653
Brand
Bellema
Company
Guangdong Horigen Mother & Baby Products Co., Ltd.
Model
XN-2301SY
Device description
manual 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
HGYPump, Breast, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGYPump, Breast, Non-PoweredObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
46940657966651PackageGS120In Commercial Distribution
06940657966653PrimaryGS10
11161105210001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4694065796665146940657966651
06940657966653069406579666536940657966653
1116110521000111161105210001

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, manualA hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.

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
06940657922062BellemaXN-2208H22017-12-23
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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