Identity
- Trade Name
- Red Tunica FDA UDI
- Generic Name
- Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- RT-20130 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- RT-20130 FDA UDI
- Primary DI / UDI-DI
- 00810160810414 FDA UDI
- FDA Product Code
- JPH FDA UDI
- GMDN Term
- Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.6700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD
Red Tunica by Rodimedi & Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rodimedi & Associates, Inc.
Sources (1)
- FDA UDI ecded874-e12d-4303-80e1-37c684b90bd7 35 fields · synced Jun 1, 2026