FDA.reportPublic FDA data

Vista ®

Primary DI
05020583252011
Brand
Vista ®
Company
TERUMO BCT, INC.
Model
25201
Device description
Vista Information System, Version 4.2
Published
2016-09-15
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
MMHSOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMHBlood Establishment Computer Software And AccessoriesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0700010
BK1502280

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0700010
BK1502280

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05020583252011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05020583252011050205832520115020583252011

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)339-4228FDAUDIprogram@terumobct.com

Regulatory Flags#

DUNS number
801679200
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05020583103108Spectra Optia®103102016-09-15
05020583610002Spectra Optia®610002016-09-15
05020583001145Reveos® Automated Whole Blood Processing System240002025-08-06
05020583826502Trima Accel826502023-06-19
05020583803664Trima Accel® 803662017-02-15
05020583804005Trima Accel®804002016-09-15
05020583824089Trima Accel® 824082016-09-15
05020583826601Trima Accel® 826602016-09-15
05020583826663Trima Accel® 826662017-02-15
05020583700512Blood Component Sampling Sets700512016-09-15
05020583803565Trima Accel® 803562017-02-15
05020583804401Trima Accel® 804402016-09-15
05020583824409Trima Accel® 824402016-09-15
05020583803503Trima Accel® 803502016-09-15
05020583803701Trima Accel® 803702016-09-15
05020583803404Trima Accel® 803402016-09-15
05020583803602Trima Accel® 803602016-09-15
05020583807006Trima Accel® 807002016-09-15
05020583804500Trima Accel® 804502016-09-15
05020583805002Trima Accel® 805002016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142373807SoftBankSCC SOFT COMPUTERMMH2026-04-29
1928342896382100Donor-IDHEALTHCARE ID, INC.MMH2026-04-10
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
00810142372039SoftBankSCC SOFT COMPUTERMMH2025-10-04
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