FDA.reportPublic FDA data

McKesson

Primary DI
40612479200119
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
603
Device description
CENTRIFUGE, MICRO-HEMATOCRIT
Published
2016-12-09
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
40612479200119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247920011940612479200119

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
023904428
Device count
1
Premarket exempt
true
Serial number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10612479235592McKesson16-18502020-06-10
10612479235608McKesson16-18522020-06-10
10612479258317McKesson16-18602020-06-25
10612479258348McKesson16-18622020-06-25
20612479203710McKesson326302020-07-21
10612479169064McKesson101-87032016-12-09
10612479169125McKesson101-87102016-12-09
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26

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
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