FDA.reportPublic FDA data

SP

Primary DI
20630140008495
Brand
SP
Company
Cardinal Health 200, LLC
Model
B3158-2
Catalog number
B3158-2
Device description
Certified Blood Bank Saline; Stabilized Isotonic Saline; Contains No Preservatives; For In Vitro Diagnostic Use Only; Not for Infusion, Injection, or Irrigation; 4 liters
Published
2018-12-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
GIFDILUENT, BLOOD CELL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIFDiluent, Blood CellHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50630140008496PackageGS14Not in Commercial Distribution
20630140008495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5063014000849650630140008496
2063014000849520630140008495

GMDN Terms#

Term, Definition table
TermDefinition
Red cell antibody diluent IVD, reagentA substance or reactant that is an antibody-free solution intended to be used as a diluent in the immunohaematological testing of a clinical specimen for the semi-quantitative determination of a red blood cell antibody, using a serial dilution or titration technique.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414289953Atellica HEMA DiluentSiemens Healthcare Diagnostics Inc.GIF2026-02-06
00630414289960Atellica HEMA DiluentSiemens Healthcare Diagnostics Inc.GIF2026-02-06
14562185395393CL AIA-PACK SAMPLE DILUTING REAGENT ATOSOH CORPORATIONGIF2025-09-01
14562185399650CL AIA-PACK SAMPLE DILUTING REAGENT DTOSOH CORPORATIONGIF2025-09-01
14562185399681CL AIA-PACK Progesterone SAMPLE DILUTING REAGENTTOSOH CORPORATIONGIF2025-09-01
24562185395390CL AIA-PACK SAMPLE DILUTING REAGENT ATOSOH CORPORATIONGIF2025-09-01
24562185399657CL AIA-PACK SAMPLE DILUTING REAGENT DTOSOH CORPORATIONGIF2025-09-01
24562185399688CL AIA-PACK Progesterone SAMPLE DILUTING REAGENTTOSOH CORPORATIONGIF2025-09-01
EBUHBCCRSTB5CAST® Stimulation Buffer BasophilBühlmann Laboratories AGGIF2025-03-04
06903053010702M-30D Diluent Shenzhen Mindray Bio-Medical Electronics Co., Ltd.GIF2025-01-17
06944904093178M-53D Diluent Shenzhen Mindray Bio-Medical Electronics Co., Ltd.GIF2025-01-17
07350040796399Medonic M51-D DiluentBoule Medical ABGIF2024-10-04
07350040796429Swelab Lumi-D DiluentBoule Medical ABGIF2024-10-04
008168700234960 Calibrator Matrix For Multi-LigandsMONOBIND, INC.GIF2024-09-13
008168700235020 Calibrator Matrix for FSH, Ferritin, Folate & Vit B12MONOBIND, INC.GIF2024-09-13
008168700235190 Calibrator Matrix for Steroid (All) and Thyroid (T3, T4)MONOBIND, INC.GIF2024-09-13
00816870023526Serum Diluent Concentrate 10X (20.1ml) for High-Value x-H Pylori, x-Tg and x-TPOMONOBIND, INC.GIF2024-09-13
00816870024035Sample Diluent hCG-Free for High-Value Pregnancy SamplesMONOBIND, INC.GIF2024-09-13
00380740136024AlinityAbbott GmbHGIF2023-11-16
15099590744847DxHBeckman Coulter, Inc.GIF2023-08-10
15099590744830DxHBeckman Coulter, Inc.GIF2023-08-04
08719189137194Starrsed DiluentRR Mechatronics Manufacturing B.V.GIF2023-07-25
00630414237701Atellica Multi-Diluent 15Siemens Healthcare Diagnostics Inc.GIF2023-06-02
00630414246826Atellica Multi-Diluent 15Siemens Healthcare Diagnostics Inc.GIF2023-06-02
10758750005024VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GIF2023-05-12
20758750005021VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GIF2023-05-12
04987562408382UF II PACK-SEDSYSMEX CORPORATIONGIF2022-11-30
04987562408399UF II PACK-BACSYSMEX CORPORATIONGIF2022-11-30
04987562422944CELLPACK DSTSYSMEX CORPORATIONGIF2022-11-30
04987562422951CELLPACK DFLSYSMEX CORPORATIONGIF2022-11-30