Silicone Nipple Shields (2pcs)

Basic Information

• Brand Name: Silicone Nipple Shields (2pcs)
• Primary DI: 09420060202021
• Version / Model: AMZ009
• Company Name: THINK GREEN LIMITED
• Labeler DUNS: 595005923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-17
• Public Version: 1
• Public Version Date: 2024-12-25
• Public Version Status: New
• Public Device Record Key: 9a18d313-c222-463a-8a45-e7c0f4f06cd0
• Distribution End Date: 2060-09-30

Device Description

A manual, silicone breast pump that uses natural suction to draw out milk from the breast or collect let-down during breastfeeding

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HFS	Shield, Nipple	General Hospital	880.5630	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43272	Nipple pad/ring, reusable	A device intended to be worn directly over the breast/nipple of a nursing woman between breast feedings to help protect the nipple from chafing, due to friction from clothing, and/or to treat sore/cracked nipples; it may also be intended to absorb leaking breast milk. It may be in the form of a fabric or cotton pad (commonly known as a nursing pad), a dome-shaped gel (e.g., hydrogel) cover, or a ring. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09420060202021	GS1