IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Blood

Product NDC
53877-105
11-digit product format
538770105
Labeler code
53877
Product ID
53877-105_d1e10bfe-e386-4d21-9235-15ef3953e08f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anticoagulant Citrate Phosphate Dextrose (CPD) and AS-5 Red Cell Preservative
Dosage form
KIT
Labeler
Terumo Corporation
Application
BN880217
Marketing category
NDA
Marketing start
2010-12-15
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Blood
Listing expiration
2026-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
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dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53877-105-01IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Bloo1 in 1 BLISTER PACKKIT12
53877-105-02IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Bloo1 in 1 BAGKIT12
53877-105-06IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Bloo15 in 1 CASEKIT152
53877-111-70IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Bloo70 mL in 1 BAGSOLUTION70 mL2.22 g in 1000mL2
53877-121-11IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) and OPTISOL (AS-5) Red Cell Preservative for collection of 500mL of Bloo111 mL in 1 BAGSOLUTION111 mL877 mg in 100mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53877-105IMUFLEX WB-SP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (SAVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE FOR COLLECTION OF 500ML OF BLOOD (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVE) KIT [TERUMO CORPORATION]2Current NDC, 5 package rows20250101_ebaeef7d-abb9-4327-bb34-18d146a07376.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53877-105-01538770105011 in 1 BLISTER PACKHistorical
53877-105-02538770105021 in 1 BAGHistorical
53877-105-065387701050615 BLISTER PACK in 1 CASE (53877-105-06) / 1 BAG in 1 BLISTER PACK (53877-105-01) / 1 KIT in 1 BAG (53877-105-02) * 70 mL in 1 BAG (53877-111-70) * 111 mL in 1 BAG (53877-121-11) 15 blister pack2010-12-15NoNoCurrent
53877-111-705387701117070 mL in 1 BAG70 mlHistorical
53877-121-1153877012111111 mL in 1 BAG111 mlHistorical