FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380168558
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
B4515-9
Catalog number
B4515-9
Device description
DISPETTE 2 PLUGGED WESTERGREN
Published
2019-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
50885380168558PackageGS110In Commercial Distribution
20885380168557PrimaryGS10
10885380168550Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538016855850885380168558
2088538016855720885380168557
1088538016855010885380168550

GMDN Terms#

Term, Definition table
TermDefinition
Erythrocyte sedimentation rate (ESR) IVD, kitA collection of reagents and other associated materials intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038917124935ESR RACK N/BACK PANELSarstedt Aktiengesellschaft & Co.KGJPH2026-07-21
00810160810414Red TunicaRodimedi & Associates, Inc.JPH2025-03-14
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