FDA.reportPublic FDA data

McKesson

Primary DI
40612479200102
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
602
Device description
Centrifuge 6 Place Fixed Angle Rotor Variable Speed up to 4,000 RPM
Published
2022-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
40612479200102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247920010240612479200102

GMDN Terms#

Term, Definition table
TermDefinition
Microhaematocrit centrifuge IVDAn electrically-powered device intended to be used for the processing of whole blood specimens using centrifugal force to determine the haematocrit, i.e., the ratio of red blood cell volume to whole blood volume expressed as a decimal, fraction, or percentage. The device typically requires a smaller sample volume than 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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
00304040043370Henry ScheinHENRY SCHEIN, INC.GKG2022-04-22
00831829000410HemataSTAT II Centrifuge SEPARATION TECHNOLOGY, INC.GKG2022-03-31
04050674026284BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674026338BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674026345BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674026383BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674026772BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674068369BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674077149BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674078856BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674079037BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674082839BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674092487BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674092494BucketAndreas Hettich GmbH & Co. KGGKG2021-09-03
04050674027663Angle rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
04050674027748Angle rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
04050674027830Angle rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
04050674027854Angle rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
04050674028318Angle rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
04050674028325Angle rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
04050674030076Swing-out rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
04050674030151Swing-out rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
04050674030380Swing-out rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
04050674077316Swing-out rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
04050674079020Swing-out rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02