Bili-Bonnet

Basic Information

• Brand Name: Bili-Bonnet
• Primary DI: 00815090010019
• Version / Model: 01B
• Catalog Number: 01B
• Company Name: SMALL BEGINNINGS INC
• Labeler DUNS: 002657679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-03
• Public Version: 1
• Public Version Date: 2020-08-11
• Public Version Status: New
• Public Device Record Key: 39e7438a-4a5e-4479-90ef-45f4e06c5d53

Device Description

Bili-Bonnet Newborn size phototherapy masks to protect infants eyes from phototherapy for treatment of jaundice.

Device Characteristics

• Single Use: Yes
• 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
FOK	Pad, Neonatal Eye	General Hospital	880.5270	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11661	Eye pad	A cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10815090010016	GS1	BOX	50	In Commercial Distribution
Primary	00815090010019	GS1
Package	20815090010013	GS1	CASE	4	In Commercial Distribution

Customer Contacts

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