FDA.reportPublic FDA data

Grafco

Primary DI
M368410E1
Brand
Grafco
Company
GF HEALTH PRODUCTS, INC.
Model
410E
Device description
Hematocrit Centrifuge
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
M368410E1PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

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