Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A) REF SIZE CASE PN 9350-10 30 mL 10 Vials/Case PN 9350-25 30 mL 25 Vials/Case It is recommended that the product be stored at ambient room temperature, 24 °C (75 °F); however, the product can be stored between 15 °C (59 °F) and 30 °C (86 °F). Protect from freezing and exposure to excessive heat should be minimized.; PRINCIPAL DISPLAY PANEL - 10 Vial Case Label C E 0044 ACD-A Anticoagulant Citrate Dextrose Solution, 10 Vials / Case Solution A, U.S.P., ACD-A, 30 mL REF PN 9350-10 WARNING: NOT FOR DIRECT INTRAVENOUS INFUSION Used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to PRP Systems manufacturer's Directions for Use. Manufactured & Distributed by: Citra Labs A Biomet Inc. Company. Citra Labs, LLC. 55 Messina Drive, Braintree, MA 02184 1-800-299-3411 EC REP Authorized Representative: Biomet Global Supply Chain Center B.V. Hazeldonk 6530 4836 LD Breda The Netherlands STERILE • NON-PYROGENIC Composition per 10 mL of Solution: Citric Acid, (Anhydrous), U.S.P. 0.073 g. Sodium Citrate, (Dihydrate), U.S.P. 0.220 g. Dextrose, (Monohydrate), U.S.P. 0.245 g. CAUTION: Single Procedure Use-Discard Unused Portion Do Not Use Unless Solution is Clear and Seal is Intact. Store Between 15 °C - 30 °C (59 °F - 86 °F). RX Only: EXP DATE LOT LA9350-10B 01/20 symbols label; PRINCIPAL DISPLAY PANEL - 25 Vial Case Label C E 0044 ACD-A Anticoagulant Citrate Dextrose Solution, 25 Vials / Case Solution A, U.S.P., ACD-A, 30 mL REF PN 9350-25 WARNING: NOT FOR DIRECT INTRAVENOUS INFUSION Used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to PRP Systems manufacturer's Directions for Use. Manufactured & Distributed by: Citra Labs A Biomet Inc. Company. Citra Labs, LLC. 55 Messina Drive, Braintree, MA 02184 1-800-299-3411 EC REP Authorized Representative: Biomet Global Supply Chain Center B.V. Hazeldonk 6530 4836 LD Breda The Netherlands STERILE • NON-PYROGENIC Composition per 10 mL of Solution: Citric Acid, (Anhydrous), U.S.P. 0.073 g. Sodium Citrate, (Dihydrate), U.S.P. 0.220 g. Dextrose, (Monohydrate), U.S.P. 0.245 g. CAUTION: Single Procedure Use-Discard Unused Portion Do Not Use Unless Solution is Clear and Seal is Intact. Store Between 15 °C - 30 °C (59 °F - 86 °F). RX Only: EXP DATE LOT LA9350-25 01/20 label
- How Supplied Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A) REF SIZE CASE PN 9350-10 30 mL 10 Vials/Case PN 9350-25 30 mL 25 Vials/Case It is recommended that the product be stored at ambient room temperature, 24 °C (75 °F); however, the product can be stored between 15 °C (59 °F) and 30 °C (86 °F). Protect from freezing and exposure to excessive heat should be minimized.
- PRINCIPAL DISPLAY PANEL - 10 Vial Case Label C E 0044 ACD-A Anticoagulant Citrate Dextrose Solution, 10 Vials / Case Solution A, U.S.P., ACD-A, 30 mL REF PN 9350-10 WARNING: NOT FOR DIRECT INTRAVENOUS INFUSION Used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to PRP Systems manufacturer's Directions for Use. Manufactured & Distributed by: Citra Labs A Biomet Inc. Company. Citra Labs, LLC. 55 Messina Drive, Braintree, MA 02184 1-800-299-3411 EC REP Authorized Representative: Biomet Global Supply Chain Center B.V. Hazeldonk 6530 4836 LD Breda The Netherlands STERILE • NON-PYROGENIC Composition per 10 mL of Solution: Citric Acid, (Anhydrous), U.S.P. 0.073 g. Sodium Citrate, (Dihydrate), U.S.P. 0.220 g. Dextrose, (Monohydrate), U.S.P. 0.245 g. CAUTION: Single Procedure Use-Discard Unused Portion Do Not Use Unless Solution is Clear and Seal is Intact. Store Between 15 °C - 30 °C (59 °F - 86 °F). RX Only: EXP DATE LOT LA9350-10B 01/20 symbols label
- PRINCIPAL DISPLAY PANEL - 25 Vial Case Label C E 0044 ACD-A Anticoagulant Citrate Dextrose Solution, 25 Vials / Case Solution A, U.S.P., ACD-A, 30 mL REF PN 9350-25 WARNING: NOT FOR DIRECT INTRAVENOUS INFUSION Used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to PRP Systems manufacturer's Directions for Use. Manufactured & Distributed by: Citra Labs A Biomet Inc. Company. Citra Labs, LLC. 55 Messina Drive, Braintree, MA 02184 1-800-299-3411 EC REP Authorized Representative: Biomet Global Supply Chain Center B.V. Hazeldonk 6530 4836 LD Breda The Netherlands STERILE • NON-PYROGENIC Composition per 10 mL of Solution: Citric Acid, (Anhydrous), U.S.P. 0.073 g. Sodium Citrate, (Dihydrate), U.S.P. 0.220 g. Dextrose, (Monohydrate), U.S.P. 0.245 g. CAUTION: Single Procedure Use-Discard Unused Portion Do Not Use Unless Solution is Clear and Seal is Intact. Store Between 15 °C - 30 °C (59 °F - 86 °F). RX Only: EXP DATE LOT LA9350-25 01/20 label
Overview
Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A), is a sterile, non-pyrogenic solution of citric acid, sodium citrate, and dextrose, in water for injection. Each 10 mL of solution contains: Citric Acid, anhydrous, USP 0.073 g Sodium Citrate, dihydrate, USP 0.220 g Dextrose, monohydrate, USP 0.245 g Water for Injection, USP q.s. pH: 4.5 – 5.5 Single patient use only, on a single occasion. single use
Indications & Usage
Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P. (ACD-A), is intended for use as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.
Dosage & Administration
Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.
Warnings & Precautions
Warnings NOT FOR DIRECT INTRAVENOUS INFUSION
Contraindications
NOT FOR DIRECT INTRAVENOUS INFUSION
Adverse Reactions
Not applicable. This product is used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP).
Storage & Handling
It is recommended that the product be stored at ambient room temperature, 24 °C (75 °F); however, the product can be stored between 15 °C (59 °F) and 30 °C (86 °F). Protect from freezing and exposure to excessive heat should be minimized.
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