Bellema

Basic Information

• Brand Name: Bellema
• Primary DI: 06940657966653
• Version / Model: XN-2301SY
• Company Name: Guangdong Horigen Mother & Baby Products Co., Ltd.
• Labeler DUNS: 529354502
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2017-12-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 482052b7-8b93-41db-90a0-899b4b29722f

Device Description

manual breast pump

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	884.5150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38477	Breast pump, manual	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	46940657966651	GS1	carton	20	In Commercial Distribution
Primary	06940657966653	GS1
Unit of Use	11161105210001	GS1