Red Tunica

Basic Information

• Brand Name: Red Tunica
• Primary DI: 00810160810414
• Version / Model: RT-20130
• Catalog Number: RT-20130
• Company Name: Rodimedi & Associates, Inc.
• Labeler DUNS: 785417726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-03-14
• Public Version: 1
• Public Version Date: 2025-03-24
• Public Version Status: New
• Public Device Record Key: ecded874-e12d-4303-80e1-37c684b90bd7

Device Description

RedTunica™ SediRedi™ - Autozero Westergren ESR System is a quantitative, non-specific, erythrocyte sedimentation rate (ESR) test device that aids in the detection of inflammation or abnormality in the body from whole human blood specimens.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JPH	Test, Erythrocyte Sedimentation Rate	Hematology	864.6700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55974	Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD	An open-ended glass or plastic tube, or other dedicated vessel, intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled ruler) for the quantitative determination of the erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. 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	10810160810411	GS1
Primary	00810160810414	GS1

Customer Contacts

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