PersonalFit Flex™ Double Pumping Kit

Basic Information

• Brand Name: PersonalFit Flex™ Double Pumping Kit
• Primary DI: 00020451458533
• Version / Model: 101045853
• Company Name: MEDELA, INC.
• Labeler DUNS: 052002029
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-18
• Public Version: 1
• Public Version Date: 2023-08-28
• Public Version Status: New
• Public Device Record Key: 15f25b7b-e804-46ac-8d90-8bb72f8617cd

Device Description

Compatible with Freestyle™ and Swing Maxi™ breast pumps

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Microwave Radiation"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OHH	Breast Pump Kit	Obstetrics/Gynecology	884.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61734	Breast pump support kit, reusable	A collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20020451458537	GS1		4	In Commercial Distribution
Primary	00020451458533	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]