FDA.reportPublic FDA data

TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood

Product NDC
53877-103
11-digit product format
538770103
Labeler code
53877
Product ID
53877-103_5bc18ac1-9c3b-4005-bbf6-3b3ee0301f38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose Monohydrate, Trisodium Citrate Dihydrate, Anhydrous Citric Acid, Sodium Phosphate, Monobasic, Unspecified Form, Anhydrous Dextrose, Sodium Chloride, Mannitol, and Adenine
Dosage form
KIT
Labeler
Terumo Corporation
Application
BN880217
Marketing category
NDA
Marketing start
2010-05-05
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood
Listing expiration
2026-12-31

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b8b3dbb-b57b-4706-a7aa-daa173caffa2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
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
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53877-103-01TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood4 in 1 BLISTER PACKKIT42
53877-103-02TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood1 in 1 BAGKIT12
53877-103-06TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood6 in 1 CASEKIT62
53877-111-70TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood70 mL in 1 BAGSOLUTION70 mL25.5 g in 1000mL2
53877-121-11TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of Blood111 mL in 1 BAGSOLUTION111 mL877 mg in 100mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53877-103TERUFLEX BLOOD BAG SYSTEM WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CPD WITH OPTISOL RED CELL PRESERVATIVE SOLUTION FOR COLLECTION OF 500ML OF BLOOD (DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, ANHYDROUS CITRIC ACID, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM, ANHYDROUS DEXTROSE, SODIUM CHLORIDE, MANNITOL, AND ADENINE) KIT [TERUMO CORPORATION]2Current NDC, 5 package rows20241012_5b8b3dbb-b57b-4706-a7aa-daa173caffa2.zip

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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Reveos Select CPD with AS-5 Red Cell Preservative Solution For Collection Of 500ml Of BloodANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVETerumo BCT Vietnam CO., Ltd.58bdabc8-283a-47bd-8abe-dd9284f3f4972025-01-14Warnings, Adverse reactionsExact identifier
application number: BN880217
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 BloodANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVETerumo Corporationebaeef7d-abb9-4327-bb34-18d146a073762024-12-17WarningsExact identifier
application number: BN880217
TERUFLEX Blood with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative for Collection of 450mL of BloodDEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, ANHYDROUS CITRIC ACID, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM, SODIUM CHLORIDE, MANNITOL, AND ADENINETerumo Corporation24057196-619a-4218-8e30-35388daee92f2024-10-10WarningsExact identifier
application number: BN880217
TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant CPD with OPTISOL Red Cell Preservative Solution for Collection of 500mL of BloodDEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, ANHYDROUS CITRIC ACID, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM, ANHYDROUS DEXTROSE, SODIUM CHLORIDE, MANNITOL, AND ADENINETerumo Corporation5b8b3dbb-b57b-4706-a7aa-daa173caffa22024-10-07WarningsExact identifier
application number: BN880217
ndc (product): 53877-103
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 PreservativeANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND AS-5 RED CELL PRESERVATIVETerumo Corporation8b22a4c8-2d6e-45d5-82e2-02ef0b7130952024-08-27WarningsExact identifier
application number: BN880217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53877-103-01538770103014 in 1 BLISTER PACKHistorical
53877-103-02538770103021 in 1 BAGHistorical
53877-103-06538770103066 BLISTER PACK in 1 CASE (53877-103-06) / 4 BAG in 1 BLISTER PACK (53877-103-01) / 1 KIT in 1 BAG (53877-103-02) * 70 mL in 1 BAG (53877-111-70) * 111 mL in 1 BAG (53877-121-11) 6 blister pack2010-05-05NoNoCurrent
53877-111-705387701117070 mL in 1 BAG70 mlHistorical
53877-121-1153877012111111 mL in 1 BAG111 mlHistorical