FDA.reportPublic FDA data

Globe Scientific

Primary DI
00840095605960
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
3469R
Device description
ESR: Sedi-Rate Westergren System with 10-Place PS Rack, Pipettes and Citrate Vials, 100 Tests/Box
Published
2019-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GHCTube, Sedimentation Rate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHCTube, Sedimentation RateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840095605960PrimaryGS10
00840095611008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095605960008400956059608400956059600840095605960
00840095611008008400956110088400956110080840095611008

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106793995
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840095681674Globe ScientificGCC-P2026-03-16
00840095688840Globe Scientific 154005R2025-07-07
00840095688857Globe Scientific 154020R2025-07-07
00840095688864Globe Scientific 154035R2025-07-07
00840095688871Globe Scientific 154005RS2025-07-07
00840095688888Globe Scientific 154020RS2025-07-07
00840095688895Globe Scientific 154035RS2025-07-07
00840095688901Globe Scientific 154105RS2025-07-07
00840095688918Globe Scientific 154120RS2025-07-07
00840095688925Globe Scientific 154135RS2025-07-07
00840095688932Globe Scientific 154205RS2025-07-07
00840095688949Globe Scientific 154220RS2025-07-07
00840095688956Globe Scientific 154235RS2025-07-07
00840095688994Globe Scientific 154005F2025-07-07
00840095689007Globe Scientific 154020F2025-07-07
00840095689014Globe Scientific 154035F2025-07-07
00840095689021Globe Scientific 154005FS2025-07-07
00840095689038Globe Scientific 154020FS2025-07-07
00840095689045Globe Scientific 154035FS2025-07-07
00840095689052Globe Scientific 154105FS2025-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033891320522VACU-TECDIESSE DIAGNOSTICA SENESE SPAGHC2024-01-22
08033891320645VACU-TEC CUVETTE-LDIESSE DIAGNOSTICA SENESE SPAGHC2024-01-22
08033891320690VES-TEC CUVETTE-LDIESSE DIAGNOSTICA SENESE SPAGHC2024-01-22
08033891321086VACU-TEC S.C.DIESSE DIAGNOSTICA SENESE SPAGHC2024-01-22
08033891321093VACU-TEC S.C. STERILEDIESSE DIAGNOSTICA SENESE SPAGHC2024-01-22
04038917127653Microvette® CB 200 NCSarstedt Aktiengesellschaft & Co.KGGHC2022-11-30
04038917201360Microvette® CB 200 NCSarstedt Aktiengesellschaft & Co.KGGHC2022-11-30
08033891320546VACU-TEC DOUBLE LABELDIESSE DIAGNOSTICA SENESE SPAGHC2022-11-25
08033891320577VES-TECDIESSE DIAGNOSTICA SENESE SPAGHC2022-11-25
00840095605939Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095605946Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095605977Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095605984Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095606004Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095606028Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
00840095606059Globe ScientificGLOBE SCIENTIFIC INC.GHC2019-11-26
03661540700606Excyte® ELITechGroup B.V.GHC2016-11-24
03661540700613Excyte® ELITechGroup B.V.GHC2016-11-24
03661540700668Excyte® ELITechGroup B.V.GHC2016-11-24
03661540700675Excyte® ELITechGroup B.V.GHC2016-11-24
29120017575263VacuetteGreiner Bio-One GmbHGHC2016-09-23
39120017575260VacuetteGreiner Bio-One GmbHGHC2016-09-23
10844509000003ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
10844509000027ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
10844509000041ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
10844509000065ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
00844509000006ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
00844509000020ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
00844509000044ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19
00844509000068ESR-Vacuum tubesSTRECK, INC.GHC2016-09-19