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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
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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

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