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.
NOT FOR DIRECT INTRAVENOUS INFUSION
NOT FOR DIRECT INTRAVENOUS INFUSION
NOT FOR DIRECT INTRAVENOUS INFUSION
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).
Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.
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
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
| Class | Version | Type | Effective |
|---|---|---|---|
| ANHYDROUS CITRIC ACID Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 23731-6051-1 | Anticoagulant Citrate Dextrose A | 10 in 1 CASE | SOLUTION | 10 | 5 | |
| 23731-6051-2 | Anticoagulant Citrate Dextrose A | 25 in 1 CASE | SOLUTION | 25 | 5 | |
| 23731-6051-3 | Anticoagulant Citrate Dextrose A | 30 mL in 1 VIAL, SINGLE-USE | SOLUTION | 30 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 23731-6051 | ANTICOAGULANT CITRATE DEXTROSE A (ANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [CITRA LABS LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20230215_5bcd261e-ebba-4ecb-af22-e5aaeb04499b.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 23731-6051-5 | ML - Milliliter | 23731-6051 | fa7599c0-4738-42b4-b126-ddd505bb0628 | 1 | 2015-10-02 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Anhydrous Citric Acid | ACTIVE INGREDIENT | XF417D3PSL | 2 | |
| Dextrose Monohydrate | ACTIVE INGREDIENT | LX22YL083G | 2 | |
| Trisodium Citrate Dihydrate | ACTIVE INGREDIENT | B22547B95K | 2 | |
| Anhydrous Citric Acid | ACTIVE MOIETY | XF417D3PSL | 2 | |
| Anhydrous Dextrose | ACTIVE MOIETY | 5SL0G7R0OK | 2 |
| Product NDC | Package NDC |
|---|---|
| 23731-6051 | 23731-6051-3, 23731-6051-1, 23731-6051-2 |
| Name | UNII | Kind |
|---|---|---|
| DEXTROSE MONOHYDRATE | LX22YL083G | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | ACTIB |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | ACTIM |
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.
ACD-A acts as an anticoagulant by the action of the citrate ion chelating free ionized calcium, thus making calcium unavailable to the coagulation system.
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.
NOT FOR DIRECT INTRAVENOUS INFUSION
NOT FOR DIRECT INTRAVENOUS INFUSION
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).
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).
Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.
Caution: Federal Law (US) restricts this devise to sale by or on the order of a Physician.
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
Manufactured & Distributed by: Citra Labs™ 55 Messina Drive, Braintree, MA 02184 Phone Number: 1-800-299-3411 Authorized Representative: Biomet Global Supply Chain Center B.V. Hazeldonk 6530 4836 LD Breda The Netherlands
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
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