FDA.reportPublic FDA data

INTERCEPT Blood System

Primary DI
18717953196948
Brand
INTERCEPT Blood System
Company
CERUS CORPORATION
Model
INT100
Device description
INTERCEPT INT100 Illuminator
Published
2015-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJFIlluminator System For Blood Products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJFIlluminator System For Blood ProductsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BP1300760
BP1401430

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP1300760
BP1401430

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18717953196948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1871795319694818717953196948

GMDN Terms#

Term, Definition table
TermDefinition
Pathogen inactivation/reduction systemA system to support the procedures that selectively alters pathogen surface structures and/or, in which, substances penetrate into the pathogens and irreversibly modify their nucleic acids, thereby impeding the proliferation of pathogens in liable blood products.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-835-3523xxx@xxx.xxx

Regulatory Flags#

DUNS number
858999485
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18717953196955INTERCEPT Blood System for PlateletsINT2130B2018-05-07
18717953196962INTERCEPT Blood System for PlateletsINT2230B2018-05-07
18717953196979INTERCEPT Blood System for PlateletsINT2530B2018-05-07
18717953196993INTERCEPT Blood System for PlasmaINT3130B2020-11-09
18717953197013INTERCEPT Blood System for CryoprecipitationINT32302021-03-22
18720589190105INTERCEPT Blood System for PlasmaINT3140B2023-02-21
18720589190112INTERCEPT Blood System for PlateletsINT2140B2023-02-21
18720589190129INTERCEPT Blood System for PlateletsINT2240B2023-02-21
18720589190136INTERCEPT Blood System for PlateletsINT2540B2023-02-21
28717953196990INTERCEPT Blood System for PlasmaINT3130B2020-11-09
18717953196900INTERCEPT Blood System for PlateletsINT2110B2015-01-13
18717953196917INTERCEPT Blood System for PlateletsINT2210B2015-01-13
18717953196924INTERCEPT Blood System for PlateletsINT2510B2015-01-13
18717953196931INTERCEPT Blood System for PlasmaINT3110B2015-01-13
08720589190108INTERCEPT Blood System for PlasmaINT3140B2023-02-21
08720589190115INTERCEPT Blood System for PlateletsINT2140B2023-02-21
28720589190126INTERCEPT Blood System for PlateletsINT2240B2023-02-21
28720589190133INTERCEPT Blood System for PlateletsINT2540B2023-02-21
38717953197017INTERCEPT Blood System for CryoprecipitationINT32302021-03-22
28717953196952INTERCEPT Blood System for PlateletsINT2130B2018-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18720589190105INTERCEPT Blood System for PlasmaCERUS CORPORATIONPJF2023-02-21
18720589190112INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2023-02-21
18720589190129INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2023-02-21
18720589190136INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2023-02-21
08720589190108INTERCEPT Blood System for PlasmaCERUS CORPORATIONPJF2023-02-21
08720589190115INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2023-02-21
28720589190126INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2023-02-21
28720589190133INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2023-02-21
18717953197013INTERCEPT Blood System for CryoprecipitationCERUS CORPORATIONPJF2021-03-22
38717953197017INTERCEPT Blood System for CryoprecipitationCERUS CORPORATIONPJF2021-03-22
18717953196993INTERCEPT Blood System for PlasmaCERUS CORPORATIONPJF2020-11-09
28717953196990INTERCEPT Blood System for PlasmaCERUS CORPORATIONPJF2020-11-09
18717953196955INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2018-05-07
18717953196962INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2018-05-07
18717953196979INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2018-05-07
28717953196952INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2018-05-07
28717953196969INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2018-05-07
28717953196976INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2018-05-07
18717953196900INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2015-01-13
18717953196917INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2015-01-13
18717953196924INTERCEPT Blood System for PlateletsCERUS CORPORATIONPJF2015-01-13
18717953196931INTERCEPT Blood System for PlasmaCERUS CORPORATIONPJF2015-01-13