18mm PersonalFit™ Plus Breast shields

Basic Information

• Brand Name: 18mm PersonalFit™ Plus Breast shields
• Primary DI: 10020451464562
• Version / Model: 101046456
• Company Name: Medela LLC
• Labeler DUNS: 052002029
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2024-05-21
• Public Version: 2
• Public Version Date: 2024-09-30
• Public Version Status: Update
• Public Device Record Key: 82a3d597-fb6d-48f3-a50d-79b85565afa0

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: 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
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
Primary	10020451464562	GS1
Unit of Use	00020451464565	GS1

Customer Contacts

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