Tulips Size L

Basic Information

• Brand Name: Tulips Size L
• Primary DI: 00814079020728
• Version / Model: 63.00.16
• Catalog Number: 63.00.16
• Company Name: Ardo medical AG
• Labeler DUNS: 481670396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 2
• Public Version Date: 2020-08-07
• Public Version Status: Update
• Public Device Record Key: e570b986-c441-4929-8644-9052d3fc0bf5

Device Description

Nipple Shields Size L

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: Yes
• 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
HFS	Shield, Nipple	General Hospital	880.5630	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35337	Nipple shielding teat, reusable	A device in the form of a flexible dome with milk-flow holes designed to be worn on a nipple by a nursing mother to facilitate breast feeding when an infant has latch-on problems (i.e., aberrant suckling technique), is premature, ill, or small (suction inside the device holds the nipple in an extended position), or when the mother has flat or inverted nipples (it provides sensation deep in the mouth that stimulates the baby). It is typically made of preformed silicone materials that additionally provide nipple protection. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814079020728	GS1
Unit of Use	07640109059641	GS1

Customer Contacts

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