MAM

Basic Information

• Brand Name: MAM
• Primary DI: 00845296061003
• Version / Model: 6100
• Catalog Number: 6100-006-2-1
• Company Name: Mam USA Corporation
• Labeler DUNS: 828747233
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-28
• Public Version: 2
• Public Version Date: 2023-06-23
• Public Version Status: Update
• Public Device Record Key: f7234265-978e-4d81-b7d4-f7fe9e403c1e

Device Description

Electric Double Breast Pump (model KP053_01)

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	884.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38478	Breast pump, electric	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845296061003	GS1