Pacee Pacifier

Basic Information

• Brand Name: Pacee Pacifier
• Primary DI: 00815090010026
• Version / Model: 15A
• Catalog Number: 15A
• Company Name: SMALL BEGINNINGS INC
• Labeler DUNS: 002657679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 1
• Public Version Date: 2020-10-02
• Public Version Status: New
• Public Device Record Key: 4cf87b92-3217-463c-a62f-ac881e2c4aa3

Device Description

Lil' Pacee preemie pacifier intended to soothe infants in the NICU especially for use with respiratory products.

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: 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
MEF	Ring, Teething, Non-Fluid Filled	Dental	872.5550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17512	Infant oral pacifier	A device, designed as an artificial teat, intended to be placed in the mouths of irritable or teething infants to quiet/pacify them. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10815090010023	GS1	BOX	100	In Commercial Distribution
Primary	00815090010026	GS1
Package	20815090010020	GS1	CASE	4	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Preemie