FDA.reportPublic FDA data

Red Tunica

Primary DI
00810160810414
Brand
Red Tunica
Company
Rodimedi & Associates, Inc.
Model
RT-20130
Catalog number
RT-20130
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.
Published
2025-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JPHTest, Erythrocyte Sedimentation Rate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPHTest, Erythrocyte Sedimentation RateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810160810414PrimaryGS10
10810160810411Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810160810414008101608104148101608104140810160810414
1081016081041110810160810411

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated erythrocyte sedimentation rate (ESR) tube IVDAn 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.

Contacts#

Phone, Email table
PhoneEmail
18883159472jrodriguez@rodimedi.com

Regulatory Flags#

DUNS number
785417726
Device count
100
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810160810377Red TunicaRT-20134RT-201342025-03-14
00850036464662Red TunicaRT-20132RT-201322025-03-14
00810160810360Red TunicaRT-20134RT-201342025-03-14
10810160810411Red TunicaRT-20130RT-201302025-03-14
20850036464666Red TunicaRT-20132RT-201322025-03-14
00810160810001Red TunicaRT-34145RT-341452024-06-14
00810160810032Red TunicaRT-34148RT-341482024-06-14
00810160810063Red TunicaRT-34151RT-341512024-06-14
00810160810094Red TunicaRT-34154RT-341542024-06-14
00810160810124Red TunicaRT-34157RT-341572024-06-14
00810160810155Red TunicaRT-34163RT-341632024-06-14
00850036464808Red TunicaRT-34166RT-341662024-06-14
00810160810018Red TunicaRT-34145RT-341452024-06-14
00810160810049Red TunicaRT-34148RT-341482024-06-14
00810160810070Red TunicaRT-34151RT-341512024-06-14
00810160810100Red TunicaRT-34154RT-341542024-06-14
00810160810131Red TunicaRT-34157RT-341572024-06-14
00810160810162Red TunicaRT-34163RT-341632024-06-14
00850036464815Red TunicaRT-34166RT-341662024-06-14
00850036464440Red TunicaRT-37297RT-372972024-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810160810411Red TunicaRodimedi & Associates, Inc.JPH2025-03-14
00860011967712ZELLESR-10STERILE SAFEQUIP & CHEMICALS LLPJPH2024-07-07
00840095624572Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095682404Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095624565Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095682411Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
04038917088138ESR pipette without graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917135047ESR pipette with graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917085205ESR rack for Monovette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917085304ESR rack for S-Sedivette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917085311ESR rack for Microvette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917169943ESR pipette without graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917207607ESR pipette with graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
08033891321017ESR ControlDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
08033891321048ESR ControlDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
08033891328207ESR Control CubeDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
08033891328757ESR Control CubeDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
29120017578172VacuetteGreiner Bio-One GmbHJPH2020-09-30
29120017578189VacuetteGreiner Bio-One GmbHJPH2020-09-30
39120017578179VacuetteGreiner Bio-One GmbHJPH2020-09-30
39120017578186VacuetteGreiner Bio-One GmbHJPH2020-09-30
29120017578158VacuetteGreiner Bio-One GmbHJPH2020-09-25
39120017578155VacuetteGreiner Bio-One GmbHJPH2020-09-25
07612964013106DISPETTE®Guest Scientific AGJPH2020-06-01
07612964013113DISPETTE®Guest Scientific AGJPH2020-06-01
07612964000762DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013304DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013328DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013403DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013533DISPETTE®Guest Scientific AGJPH2019-11-07