ANTICOAGULANT CITRATE DEXTROSE A ACD-A- anticoagulant citrate dextrose a acd-a injection, solution 
Arteriocyte Medical Systems, Inc.

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Anticoagulant Citrate Dextrose Solution,
Solution A, USP

ACD-A 50 mL
Catalog # AMSACD-A

Anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. See Operator's Manuals for additional information and complete usage instructions.

Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact and undamaged.

Rx only. Single use container.

Caution

Not for preparation of blood products for transfusion or for direct intravenous infusion.

Recommended storage

Room temperature (68° to 77°F, 20° to 25°C)

Avoid excessive heat. Protect from freezing.

Each 10mL contains

Citric Acid Monohydrate USP0.08 g
Sodium Citrate Dihydrate USP0.220 g
Dextrose Monohydrate USP0.245 g
In Water for Injection USP

Manufactured for Arteriocyte Medical Systems, Inc.
45 South Street, Hopkinton, MA., 01748
by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

ARTERIOCYTE
CELLULAR THERAPIES
MEDICAL SYSTEMS

Lot
Expiry Date

PRINCIPAL DISPLAY PANEL - 50 Pouch Case Label

Anticoagulant Citrate Dextrose Solution,
Solution A USP ACD-A

50 mL
50 x 50 mL

Catalog # AMSACD-A

Anticoagulant intended for use only with devices that prepare Platelet Rich
Plasma (PRP) products for extracorporeal use. See Operator's Manuals for
additional information and complete usage instructions.

Sterile. Non-pyrogenic. Do not use unless the solution is clear and the
container is intact and undamaged. Rx only. Single use container.

Caution: Not for preparation of blood products for transfusion or for direct
intravenous infusion.

Storage Conditions: Room temperature (68° to 77°F, 20° to 25°C)
Avoid excessive heat. Protect from freezing. Protect from direct sunlight.

Each 10mL contains:

Citric Acid Monohydrate USP
0.08 g
Sodium Citrate Dihydrate USP
0.220 g
Dextrose Monohydrate USP
0.245 g
In Water for Injection USP

Manufactured for Arteriocyte Medical Systems, Inc.
45 South Street, Hopkinton, MA., 01748
by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

ARTERIOCYTE
CELLULAR THERAPIES
MEDICAL SYSTEMS

Lot
Expiry Date

PRINCIPAL DISPLAY PANEL - 50 Pouch Case Label
ANTICOAGULANT CITRATE DEXTROSE A ACD-A 
anticoagulant citrate dextrose a acd-a injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43203-852
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.08 g  in 10 mL
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE, UNSPECIFIED FORM0.220 g  in 10 mL
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE0.245 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R) 9.76 g  in 10 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43203-852-4750 in 1 CASE
11 in 1 POUCH
150 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDABA11005705/11/2011
Labeler - Arteriocyte Medical Systems, Inc. (809012870)
Registrant - Terumo BCT, Inc. (801679200)
Establishment
NameAddressID/FEIBusiness Operations
Terumo BCT, Ltd.233649834MANUFACTURE(43203-852) , ANALYSIS(43203-852) , STERILIZE(43203-852) , LABEL(43203-852)

Revised: 12/2018
Document Id: 36fd228c-a0de-42d9-90a4-c7b252a07571
Set id: b850deac-161f-4bb0-ac7f-bceac2a230c0
Version: 3
Effective Time: 20181217
 
Arteriocyte Medical Systems, Inc.