FDA.report

Pathnet Blood Bank Transfusion (L-2300)

Primary DI
05060508820000
Company
CIRDAN IMAGING LIMITED
Model
4.1
Published
2016-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
216744109
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
05060508820000PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
05060508820000PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MMHBlood Establishment Computer Software And Accessories2Hematology864.9165NEligible

Premarket Submissions

SubmissionSupplement
BK0500180

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0500180

GMDN Terms

TermDefinition
Blood bank information systemA dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, and/or distribute administrative and/or clinical data within blood-bank centres. Specific functions typically include management of blood-donor data, autologous and direct blood unit tracking (e.g., using radio-frequency identification (RFID)], and/or cross-match result determination. It consists of dedicated combined hardware (e.g., computers, terminals, network components, blood unit containers) and software.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05060508820017CoreLite12020-03-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860010612873SDNet Configurable Manual Batch EntryRubin & Poor, Inc.MMH2026-01-27
B236SQBB202420Clinisys SQ Blood BankCliniSys, IncMMH2026-01-23
B105TRANSFUSION20250WellSky TransfusionWELLSKY CORPORATIONMMH2026-01-14
03665324000067Patient Health Software (P.H.S)MAK-SYSTEM GROUP LIMITEDMMH2025-12-15
B180IMB029010Instrument ManagerDATA INNOVATIONS LLCMMH2025-12-08
00860271000969VistA Blood Establishment Computer SoftwareVETERANS AFFAIRS, UNITED STATES DEPARTMENT OFMMH2025-11-26
00810055818310SoftID.TxSCC SOFT COMPUTERMMH2025-09-06
00860011763208NDDR and CDCSCIELOWORKS, INC.MMH2025-07-16
00860014128905MediCopiaLattice IncorporatedMMH2025-06-04
00860009119406ABO Express V 2.0.0Blood Bank Computer SystemMMH2025-04-28
00860009119420Blood Bank Control System 6.0Blood Bank Computer SystemMMH2025-04-28
00860009119437ABO Wheels V 1.0.0Blood Bank Computer SystemMMH2025-04-28
00860009119444ABO QuickPass V 1.0.0Blood Bank Computer SystemMMH2025-04-28
00860009119451BBCS BloodTrack Interface ApplicationBlood Bank Computer SystemMMH2025-04-28
00860009119468BBCS Hospital Interface ApplicationBlood Bank Computer SystemMMH2025-04-28
00860009119475Blood Bank Control System, V5.0Blood Bank Computer SystemMMH2025-04-28
00860009119482BBCS Lab Interface Application V5.0Blood Bank Computer SystemMMH2025-04-28
00867268000421bexWISE APIIT SYNERGISTICS, LLCMMH2025-04-08
00850053416002Blood Product Administration ModuleEPIC SYSTEMS CORPORATIONMMH2025-02-03
1928342896382000Donor-IDHEALTHCARE ID, INC.MMH2025-01-14
B236SQBB202410Clinisys SQ Blood BankCliniSys, IncMMH2024-12-06
10888234002475ImmuLINKIMMUCOR, INC.MMH2024-12-05
03665324000050ePROGESAMAK-SYSTEM GROUP LIMITEDMMH2024-11-27
1928342896381900Donor-IDHEALTHCARE ID, INC.MMH2024-11-14
00810142371827SoftBankSCC SOFT COMPUTERMMH2024-11-13
00860010612866SDNet Configurable Manual Batch EntryRubin & Poor, Inc.MMH2024-10-15
00857222008037Blood Bank Information Management SystemCARTER BLOODCAREMMH2024-09-09
00860010651209Blood Product Questionnaire ModuleBUOY SOFTWARE, LLCMMH2024-07-24
00860271000952VistA Blood Establishment Computer SoftwareVETERANS AFFAIRS, UNITED STATES DEPARTMENT OFMMH2024-06-14
00810055815647SoftBankSCC SOFT COMPUTERMMH2024-06-12