bili-ruler

Basic Information

• Brand Name: bili-ruler
• Primary DI: 00810101280498
• Version / Model: 0
• Catalog Number: 0203A
• Company Name: LITTLE SPARROWS TECHNOLOGIES LLC
• Labeler DUNS: 078764736
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-07
• Public Version: 1
• Public Version Date: 2026-04-15
• Public Version Status: New
• Public Device Record Key: 700593d1-c48b-4afa-aaa4-03bf58626794

Device Description

Jaundice Screening Device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: No
• 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
HIT	Tester, Color Vision	Ophthalmic	886.1170	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16166	Transcutaneous bilirubinometer	A noninvasive, battery-powered, hand-held, portable instrument intended to measure transcutaneous bilirubin (TcB) levels, in order to predict total serum bilirubin (TSB) levels in a neonate. It directs a light beam into the newborn’s skin, usually on the forehead, sternum or ear, and measures the intensity of multiple wavelengths (typically 2 or more) that are reflected from the newborns subcutaneous tissue. These optical signals are processed (typically by a photocell and microprocessor) to give a TcB and/or TSB value. It is used mainly for screening hyperbilirubinemia.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810101280498	GS1