O-Cal-ette

Basic Information

• Brand Name: O-Cal-ette
• Primary DI: 00308130099001
• Version / Model: 9900
• Catalog Number: 009900
• Company Name: PHARMICS, INC.
• Labeler DUNS: 058560996
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-17
• Public Version: 3
• Public Version Date: 2020-08-07
• Public Version Status: Update
• Public Device Record Key: e0175948-c0dc-45d7-af50-219bee1eecd4

Device Description

Nursing Cup

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: No
• 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
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	00308130099001	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3.38	Inch