imuflex wb-sp blood bag system with integral whole blood leukocyte reduction filter (saving platelets) with diversion blood sampling arm

Product NDC
53877-010
11-digit product format
538770010
Labeler code
53877
Product ID
53877-010_dcde5c97-a5cb-43fb-b890-296a0a67b22f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anticoagulant Citrate Phosphate Dextrose (CPD)
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Terumo Corporation
Application
BN880217
Marketing category
NDA
Marketing start
2019-02-11
Marketing end
0000-00-00
Substance
DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active strength
2 g/70mL; g/70mL; mg/70mL; mg/70mL
Pharmacologic classes
Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53877-010-015387700100110 POUCH in 1 CARTON (53877-010-01) > 1 BAG in 1 POUCH > 70 mL in 1 BAG10 pouch2019-02-110000-00-00NoNoCurrent