FDA.report

SDNet Configurable Manual Batch Entry

Primary DI
00860010612866
Brand
SDNet Configurable Manual Batch Entry
Company
Rubin & Poor, Inc.
Model
CTS 1.5A
Catalog number
4
Device description
Configurable Software for managing manually entered blood test results.
Published
2024-10-15
Public version status
New
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

Product Codes

CodeName
MMHBlood Establishment Computer Software And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
MMHBlood Establishment Computer Software And AccessoriesHematology2

Premarket Submissions

SubmissionSupplement
BK0300730

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0300730

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860010612866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010612866008600106128668600106128660860010612866

GMDN Terms

TermDefinition
Blood bank information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute administrative and clinical data within blood-bank centres. It accumulates data on blood-donor status and may include algorithms to process blood-bank information. It may perform additional tasks such as autologous and direct unit tracking, cross-match result determination, and/or management of bar-code information and patient history reports. It is typically supplied for installation into a blood bank information system, or mainframe or decentralized computers/networks.

Sterilization Methods

Method

Regulatory Flags

DUNS number
113898907
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00860010612873SDNet Configurable Manual Batch EntryCTS 1.6A42026-01-27
00860010612804SDNet Configurable Laboratory Result Manager MBC 1.0B12024-03-01
00860010612811SDNet Configurable Manual Batch EntryMBC 1.0B22024-03-01
00860010612828SDNet Configurable Laboratory Result ManagerCTS 1.4A32024-03-01
00860010612835SDNet Configurable Manual Batch EntryCTS 1.4A42024-03-01
00860010612842SDNet Configurable Laboratory Result ManagerQTX - V1.0e(WinSQL 1.0d)52024-03-01
00860010612859SDNet Configurable Manual Batch EntryQTX - V1.1a(WinSQL 1.0c)62024-03-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860010612873SDNet Configurable Manual Batch EntryRubin & Poor, Inc.MMH2026-01-27
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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
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
B10520241WellSky Blood Centers WELLSKY CORPORATIONMMH2024-05-31