FDA.reportPublic FDA data

Thermo Scientific Pacific Hemostasis®

Primary DI
00845275000702
Brand
Thermo Scientific Pacific Hemostasis®
Company
Fisher Diagnostics
Model
100070
Published
2016-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GJTPlasma, Coagulation Factor Deficient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJTPlasma, Coagulation Factor DeficientHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275000702PrimaryGS10
00845275005479Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275000702008452750007028452750007020845275000702
00845275005479008452750054798452750054790845275005479

GMDN Terms#

Term, Definition table
TermDefinition
Plasma protein IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of plasma proteins in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-528-0494xx@xx.xx

Regulatory Flags#

DUNS number
183998769
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845275002751Thermo Scientific Infinity™TR254212016-09-16
00845275000504Thermo Scientific Pacific Hemostasis®1003012016-09-16
00845275000559Thermo Scientific Pacific Hemostasis®1005952016-09-16
00845275000566Thermo Scientific Pacific Hemostasis®1005962016-09-16
00845275000573Thermo Scientific Pacific Hemostasis®1005972016-09-16
00845275000580Thermo Scientific Pacific Hemostasis®1006012016-09-16
00845275000634Thermo Scientific Pacific Hemostasis®1003082016-09-16
00845275000658Thermo Scientific Pacific Hemostasis®1003122016-09-16
00845275000818Thermo Scientific Pacific Hemostasis®1005602016-09-16
00845275000832Thermo Scientific Pacific Hemostasis®1006032016-09-16
00845275000849Thermo Scientific Pacific Hemostasis®1006062016-09-16
00845275000016Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers OSR611542025-11-18
00845275000405Thermo Scientific TR360262016-09-16
00845275001068Thermo Scientific 12452502016-09-16
00845275002973Thermo Scientific TR333212016-09-16
00845275005431Thermo Scientific for Beckman Coulter SYNCHRON and UnuCel SystemsA466602016-09-16
00845275004717Thermo Scientific Nerl®JDIL55222019-08-13
00845275003031Thermo Scientific Infinity™TR351212016-09-16
00845275000528Thermo Scientific Pacific Hemostasis®1003532016-09-16
00845275000535Thermo Scientific Pacific Hemostasis®1003542016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414639598Coagulation Factor X Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414639604Coagulation Factor XI Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640587Coagulation Factor IX Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640679Coagulation Factor XII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640686Coagulation Factor II Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640761Coagulation Factor VIII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640792Coagulation Factor VII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018817Coagulation Factor X Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018879Coagulation Factor XI Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018824Coagulation Factor IX Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018862Coagulation Factor XII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018855Coagulation Factor II Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018831Coagulation Factor VIII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00842768018848Coagulation Factor VII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-03-25
00630414640754Coagulation Factor V Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-02-19
00842768018886Coagulation Factor V Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2024-02-19
00843876000572CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic IncGJT2023-09-25
00843876000589CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic IncGJT2023-09-25
00843876010557CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic IncGJT2023-09-25
00843876010564CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic IncGJT2023-09-25
00815696021310George King Factor VIII Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGJT2022-03-03
00815696021211George King Factor V Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGJT2020-02-27
00815696021075George King FVII Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGJT2017-06-26
00815696021082George King FVII Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGJT2017-06-26
00815696021037George King Congential Factor Deficiency Convenience KitGEORGE KING BIO-MEDICAL, INCGJT2017-03-20
10859394006153NoFact VIIIR 2 DIAGNOSTICS, INC.GJT2016-11-15
10859394006160NoFact IXR 2 DIAGNOSTICS, INC.GJT2016-11-15
00842768009525Coagulation Factor V Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2016-09-24
00842768009976Coagulation Factor XI Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2016-09-24
00842768009990Coagulation Factor XII Deficient PlasmaSiemens Healthcare Diagnostics Products GmbHGJT2016-09-24