INTERCEPT Blood System for Plasma

Primary DI
08720589190108
Brand
INTERCEPT Blood System for Plasma
Company
CERUS CORPORATION
Model
INT3140B
Device description
INTERCEPT Blood System for Plasma, Plasma (P) Processing Set (Semi-Integrated Set)
Published
2023-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
BP13007660

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP13007660

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28720589190102PackageGS14In Commercial Distribution
18720589190105PrimaryGS10
08720589190108Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2872058919010228720589190102
1872058919010518720589190105
08720589190108087205891901088720589190108

GMDN Terms#

Term, Definition table
TermDefinition
Donor blood photochemical treatment kitA collection of sterile devices and reagent solution intended to be used in vitro with an ultraviolet (UV) blood illuminator for photochemical treatment of donor blood (including whole blood, plasma, and/or platelet concentrates) to inactivate blood transfusion-associated pathogens and white blood cells, and for subsequent storage. It includes plastic illumination and storage bags and tubing, and a photoactive reagent (e.g., riboflavin, psoralen) solution; a sampling bag for quality control and a compound adsorption device used post-irradiation to reduce the levels of photoactive reagent in the final suspension may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
858999485
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
18717953196948INTERCEPT Blood SystemINT1002015-01-13
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
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
18717953196948INTERCEPT Blood SystemCERUS CORPORATIONPJF2015-01-13