FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040039519
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1126910
Catalog number
1126910
Device description
CENTRIFUGE MIRCROHEMATOCR
Published
2016-12-05
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
00304040039519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040039519003040400395193040400395190304040039519

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
012430880
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040195472Essentials570582857058282026-09-04
10304040195489Essentials570582957058292026-09-04
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008318290004413D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)SEPARATION TECHNOLOGY, INC.GKG2023-11-06
008318290004583D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)SEPARATION TECHNOLOGY, INC.GKG2023-11-06
00840095655699Globe ScientificGLOBE SCIENTIFIC INC.GKG2023-07-05
00664816005651LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2023-01-30
00664816005668LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2023-01-30
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
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04050674026338BucketAndreas Hettich GmbHGKG2021-09-03
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04050674026383BucketAndreas Hettich GmbHGKG2021-09-03
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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