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Reveos Select CPD/AS-5 Red Cell Preservative For Collection Of Blood

REVEOS SELECT SET CPD WITH AS-5 RED CELL PRESERVATIVE SOLUTION FOR COLLECTION OF 500 mL OF BLOOD Terumo BCT, Inc. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use the Reveos SELECT set safely and effectively. See full prescribing information for the Reveos SELECT set. REVEOS SELECT SET Sterile Fluid PVC Plasticized With DEHP Bag Initial U.S. Approval: TBD

Approved
Approval ID

58bdabc8-283a-47bd-8abe-dd9284f3f497

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 28, 2023

Manufacturers
FDA

Terumo BCT Vietnam CO., Ltd.

DUNS: 555361198

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dextrose Monohydrate, Trisodium Citrate Dihydrate, Anhydrous Citric Acid, and Sodium Phosphate, Monobasic, Unspecified Form

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82906-506
Application NumberBN880217
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose Monohydrate, Trisodium Citrate Dihydrate, Anhydrous Citric Acid, and Sodium Phosphate, Monobasic, Unspecified Form
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 1, 2023
FDA Product Classification

INGREDIENTS (5)

Dextrose MonohydrateActive
Quantity: 1.624 g in 70 mL
Code: LX22YL083G
Classification: ACTIB
Sodium Phosphate, Monobasic, Unspecified FormActive
Quantity: 0.176 g in 70 mL
Code: 3980JIH2SW
Classification: ACTIB
Anhydrous Citric AcidActive
Quantity: 0.229 g in 70 mL
Code: XF417D3PSL
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Trisodium Citrate DihydrateActive
Quantity: 1.841 g in 70 mL
Code: B22547B95K
Classification: ACTIM

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Reveos Select CPD/AS-5 Red Cell Preservative For Collection Of Blood - FDA Drug Approval Details