UNISTAT® Bilirubinometer Specimen Cuvettes

Basic Information

• Brand Name: UNISTAT® Bilirubinometer Specimen Cuvettes
• Primary DI: 00812559011136
• Version / Model: 13102140
• Company Name: REICHERT, INC.
• Labeler DUNS: 126650253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 51
• Record Status: Published
• Publish Date: 2025-08-12
• Public Version: 1
• Public Version Date: 2025-08-20
• Public Version Status: New
• Public Device Record Key: 918ee381-12cf-40e9-90ec-e665cdb95ba7

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: No
• Has Serial Number: Yes
• 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
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	862.1113	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61032	Laboratory analyser cuvette IVD, single-use	A small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for in vitro diagnostic testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through the contained material and is typically made of plastic, glass or quartz with a flat base and an open top. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00812559011143	GS1
Primary	00812559011136	GS1

Premarket Submissions

Submission Number	Supplement Number
K922770	000