FDA.reportPublic FDA data

INTERCEPT Blood System for Cryoprecipitation

Primary DI
18717953197013
Brand
INTERCEPT Blood System for Cryoprecipitation
Company
CERUS CORPORATION
Model
INT3230
Device description
INTERCEPT Blood System for Cryoprecipitation
Published
2021-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
BP13007634

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP13007634

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38717953197017PackageGS18In Commercial Distribution
18717953197013PrimaryGS10
08717953197016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3871795319701738717953197017
1871795319701318717953197013
08717953197016087179531970168717953197016

GMDN Terms#

Term, Definition table
TermDefinition
Blood washing/centrifugation bagA flexible container intended to be used to facilitate blood processing via blood washing and/or centrifugation (e.g., cryoprecipitation) to achieve separation of blood components [e.g., red blood cells (RBCs), platelets, plasma], typically to generate a blood product from autologous or donor blood for procedural (e.g., surgical haemostasis) or transfusion applications [e.g., fibrinogen rich cryoprecipitate]. It is additionally intended to be used as a blood storage bag, and is made of flexible durable materials that withstand centrifugation and freezing/thawing. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius26 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
858999485
Device count
6
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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
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
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