FDA.reportPublic FDA data

NDC 53877-006-01 - IMUFLEX WB-RP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Removing Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53877-006
Requested NDC
53877-006-01
Package NDCs from labels
53877-006-02, 53877-006-01, 53877-006-06
Manufacturer
Terumo Corporation | Terumo Corp. - Fujinomiya Factory
Effective date
2024-08-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Anticoagulant Citrate Phosphate Dextrose (CPD) - Terumo Corporation | Terumo Corp. - Fujinomiya FactoryTerumo Corporation | Terumo Corp. - Fujinomiya Factory2024-08-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53877-006-01IMUFLEX WB-RP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Removing Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative3 in 1 BLISTER PACKKIT37
53877-006-02IMUFLEX WB-RP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Removing Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative1 in 1 BAGKIT17
53877-006-06IMUFLEX WB-RP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Removing Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative6 in 1 CASEKIT67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53877-006IMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]7Current NDC, Legacy NDC, 3 package rows20240830_8b22a4c8-2d6e-45d5-82e2-02ef0b713095.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AdenineACTIVE INGREDIENTJAC85A2161IMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
Anhydrous Citric AcidACTIVE INGREDIENTXF417D3PSLIMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
Dextrose MonohydrateACTIVE INGREDIENTLX22YL083GIMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
MannitolACTIVE INGREDIENT3OWL53L36AIMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
Sodium ChlorideACTIVE INGREDIENT451W47IQ8XIMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
Sodium Phosphate, MonobasicACTIVE INGREDIENT3980JIH2SWIMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
Trisodium Citrate DihydrateACTIVE INGREDIENTB22547B95KIMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
AdenineACTIVE MOIETYJAC85A2161IMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
Citric AcidACTIVE MOIETY2968PHW8QPIMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
DextroseACTIVE MOIETYIY9XDZ35W2IMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
MannitolACTIVE MOIETY3OWL53L36AIMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
Phosphoric AcidACTIVE MOIETYE4GA8884NNIMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
SODIUM CATIONACTIVE MOIETYLYR4M0NH37IMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2
WaterINACTIVE INGREDIENT059QF0KO0RIMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 19 of 62 · 1,234 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: 451W47IQ8X
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.c1677d70-203b-493e-88f0-815a66133f1d2025-11-20WarningsExact identifier
unii: 3980JIH2SW
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCce0c8c6f-734a-400f-9b60-a3b1e263f25f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATER J General Corporationdbb0d067-71f0-45e4-bc98-548cf4a90b3a2025-11-17WarningsExact identifier
unii: XF417D3PSL
Sodium ChlorideSODIUM CHLORIDE TABLETSKesin Pharma Corporation2f107592-10c5-ef3b-e063-6394a90a7c0a2025-11-17WarningsExact identifier
unii: 451W47IQ8X
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
ALUMIZENGARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED.Natural Creations, Inc.4760ab09-1141-4944-b840-804ae6d86d2d2025-11-13WarningsExact identifier
unii: 451W47IQ8X
BLISTER HPJUGLANS CINEREA BRANCH BARK/ROOT BARK, POTASSIUM IODIDE, LYCOPODIUM CLAVATUM SPORE, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG.Natural Creations, Inc.e76f05e7-6d7b-4d2e-ba26-bf776bf0e6572025-11-13WarningsExact identifier
unii: 451W47IQ8X
Anxiety HPARSENIC TRIOXIDE, CALCIUM CARBONATE, STRYCHNOS IGNATII SEED, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLANatural Creations, Inc.13d92246-c20e-47a8-b88f-22da876fc5452025-11-13WarningsExact identifier
unii: 451W47IQ8X
ANXIETY II HPACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, HUMAN BREAST TUMOR CELL, CAUSTICUM, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAFNatural Creations, Inc.02fa45a5-08e1-41ad-acd4-0f85db07e89e2025-11-13WarningsExact identifier
unii: 451W47IQ8X
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.