Easy Freeze

Basic Information

• Brand Name: Easy Freeze
• Primary DI: 00814079020216
• Version / Model: 63.00.207
• Catalog Number: 63.00.207
• Company Name: Ardo medical AG
• Labeler DUNS: 481670396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e9eb1112-2906-4699-b1e2-01904cc5b117

Device Description

Easy Freeze breast milk bags for safe and space-saving storage of breast milk in your fridge or freezer.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
45136	Breast milk bag	A sterile flexible sac designed for the collection and storage of breast milk. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814079020216	GS1
Package	00814079020223	GS1	Box	18	In Commercial Distribution
Unit of Use	00814079020230	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141742	000