UNISTAT® Bilirubinometer Specimen Cuvettes

GUDID 00812559011143

REICHERT, INC.

Laboratory analyser cuvette IVD, single-use

• Primary Device ID: 00812559011143
• NIH Device Record Key: 918ee381-12cf-40e9-90ec-e665cdb95ba7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNISTAT® Bilirubinometer Specimen Cuvettes
• Version Model Number: 13102140
• Company DUNS: 126650253
• Company Name: REICHERT, INC.
• Device Count: 51
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812559011136 [Primary]
GS1	00812559011143 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922770

FDA Product Code

• MQM: Bilirubin (Total And Unbound) In The Neonate Test System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-20
• Device Publish Date: 2025-08-12

Devices Manufactured by REICHERT, INC.

• 00812559012485 - Ocu-Film® +": 2025-08-25
• 00812559012492 - Ocu-Film® +": 2025-08-22
• 00812559010238 - Ultramatic RX Master Phoropter: 2025-08-20
• 00812559010269 - Ultramatic RX Master Phoropter: 2025-08-20
• 00812559010290 - Illuminated Phoropter: 2025-08-20
• 00812559010320 - Illuminated Phoropter: 2025-08-20
• 00812559010559 - TF50 Trial Frame: 2025-08-20
• 00812559010566 - TS75 Trial Lens: 2025-08-20