Refractix™ DSP

GUDID 00812559012522

REICHERT, INC.

Clinical specimen refractometer

• Primary Device ID: 00812559012522
• NIH Device Record Key: 9bebef21-6e6a-4a31-9d19-283e94917963
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Refractix™ DSP
• Version Model Number: 13930000
• Company DUNS: 126650253
• Company Name: REICHERT, INC.
• Device Count: 1
• 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: false
• 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	00812559012522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK170128

FDA Product Code

• PSM: Refractometer For Donor Testing

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

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• 00812559010559 - TF50 Trial Frame: 2025-08-20
• 00812559010566 - TS75 Trial Lens: 2025-08-20
• 00812559010580 - PDM Digital PD Meter: 2025-08-20