Nutricel Additive System - CP2D
CP2D/AS-3 Blood Collection and Sampling System
Approved
Approval ID
e713f9f1-4208-4ea9-b33f-d758a06346ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 13, 2013
Manufacturers
FDA
Haemonetics Manufacturing Inc
DUNS: 078598396
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CP2D/AS-3 Anticoagulant and Additive System
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53157-AS3
Application NumberNDA820915
Product Classification
M
Marketing Category
C73594
G
Generic Name
CP2D/AS-3 Anticoagulant and Additive System
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 13, 2013
FDA Product Classification
INGREDIENTS (7)
ADENINEActive
Quantity: 0.033 g in 110 mL
Code: JAC85A2161
Classification: ACTIB
DEXTROSEActive
Quantity: 1.21 g in 110 mL
Code: IY9XDZ35W2
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CP2D/AS-3 Anticoagulant and Additive System
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53157-120
Application NumberNDA820915
Product Classification
M
Marketing Category
C73594
G
Generic Name
CP2D/AS-3 Anticoagulant and Additive System
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 13, 2013
FDA Product Classification
INGREDIENTS (5)
DEXTROSEActive
Quantity: 3.57 g in 70 mL
Code: IY9XDZ35W2
Classification: ACTIB
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT