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Nutricel Additive Solution - CP2D

CP2D/AS-3 Blood Collection and Sampling System

Approved
Approval ID

6ce6f3c2-bb14-4d5e-a3b1-ddaf1348e067

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 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 Code53157-100
Application NumberBN820915
Product Classification
M
Marketing Category
C73594
G
Generic Name
CP2D/AS-3 Anticoagulant and Additive System
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 13, 2013
FDA Product Classification

INGREDIENTS (3)

CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
DEXTROSEActive
Quantity: 3.57 g in 70 mL
Code: IY9XDZ35W2
Classification: ACTIB

CP2D/AS-3 Anticoagulant and Additive System

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53157-101
Application NumberBN820915
Product Classification
M
Marketing Category
C73594
G
Generic Name
CP2D/AS-3 Anticoagulant and Additive System
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 13, 2013
FDA Product Classification

INGREDIENTS (7)

DEXTROSEActive
Quantity: 1.21 g in 110 mL
Code: IY9XDZ35W2
Classification: ACTIB
ADENINEActive
Quantity: 0.033 g in 110 mL
Code: JAC85A2161
Classification: ACTIB
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT

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Nutricel Additive Solution - CP2D - FDA Drug Approval Details