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

Basic Information

Product Name

FDA Product Code

82906-506

Regulatory Information

NDC Product Code

82906-506

Application Number

BN880217

Marketing Category

C73594

Effective Date

March 1, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

Dextrose Monohydrate

Quantity: 1.624 g in 70 mL

Code: LX22YL083G

Class Code: ACTIB

Sodium Phosphate, Monobasic, Unspecified Form

Quantity: 0.176 g in 70 mL

Code: 3980JIH2SW

Class Code: ACTIB

Anhydrous Citric Acid

Quantity: 0.229 g in 70 mL

Code: XF417D3PSL

Class Code: ACTIB

Water

Code: 059QF0KO0R

Class Code: IACT

Trisodium Citrate Dihydrate

Quantity: 1.841 g in 70 mL

Code: B22547B95K

Class Code: ACTIM

Active Moieties

Anhydrous Dextrose

Code: 5SL0G7R0OK

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

SODIUM CATION

Code: LYR4M0NH37

Basic Information

Regulatory Information

Company Information

Active Ingredients

Water

Active Moieties

Anhydrous Dextrose

ANHYDROUS CITRIC ACID

SODIUM CATION