FDA.reportPublic FDA data

Globe Scientific

Primary DI
00840095608435
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
GCH-24-EU
Device description
Centrifuge, Hematocrit, 24-Place, 230v, 50Hz, UK, Plug (includes: 24-Place Hematocrit Rotor Kit with Lid and Reading Disk Lid)
Published
2019-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GKGCentrifuge, Hematocrit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKGCentrifuge, HematocritHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840095608435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095608435008400956084358400956084350840095608435

GMDN Terms#

Term, Definition table
TermDefinition
Microhaematocrit centrifugeA tabletop- or bench-mounted mains electricity (AC-powered) device used mainly in the clinical laboratory to process through high-speed centrifugal force (typically 10,000 to 25,000 rpm) specimens of whole blood to determine the ratio of the red cell volume to the whole blood volume expressed as a decimal, fraction, or percentage. The device typically generates a relative centrifugal force (RCF) of at least 10,000 x g to efficiently pack cells in a short time (i.e., 3 to 5 minutes) and requires a smaller sample size than low-speed conventional centrifuges (macrohaematocrit method). The haematocrit is typically used to diagnose blood loss and erythrocyte count above or below normal.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106793995
Device count
1
Premarket exempt
true
Serial number
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
008318290004583D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)SEPARATION TECHNOLOGY, INC.GKG2023-11-06
00840095655699Globe ScientificGLOBE SCIENTIFIC INC.GKG2023-07-05
00664816005309LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2022-10-25
00664816005576LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2022-09-09
00664816005613LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2022-09-09
40612479200102McKessonMCKESSON MEDICAL-SURGICAL INC.GKG2022-08-31
00304040043370Henry ScheinHENRY SCHEIN, INC.GKG2022-05-03
00831829000410HemataSTAT II Centrifuge SEPARATION TECHNOLOGY, INC.GKG2022-03-31
04050674026284BucketAndreas Hettich GmbHGKG2021-09-03
04050674026338BucketAndreas Hettich GmbHGKG2021-09-03
04050674026345BucketAndreas Hettich GmbHGKG2021-09-03
04050674026383BucketAndreas Hettich GmbHGKG2021-09-03
04050674026772BucketAndreas Hettich GmbHGKG2021-09-03
04050674068369BucketAndreas Hettich GmbHGKG2021-09-03
04050674077149BucketAndreas Hettich GmbHGKG2021-09-03
04050674078856BucketAndreas Hettich GmbHGKG2021-09-03
04050674079037BucketAndreas Hettich GmbHGKG2021-09-03
04050674082839BucketAndreas Hettich GmbHGKG2021-09-03
04050674092487BucketAndreas Hettich GmbHGKG2021-09-03
04050674092494BucketAndreas Hettich GmbHGKG2021-09-03
04050674027663Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674027748Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674027830Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674027854Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674028318Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674028325Angle rotorAndreas Hettich GmbHGKG2021-09-02
04050674030076Swing-out rotorAndreas Hettich GmbHGKG2021-09-02
04050674030151Swing-out rotorAndreas Hettich GmbHGKG2021-09-02
04050674030380Swing-out rotorAndreas Hettich GmbHGKG2021-09-02
04050674077316Swing-out rotorAndreas Hettich GmbHGKG2021-09-02