FDA Label for As-3
View Indications, Usage & Precautions
As-3 Product Label
The following document was submitted to the FDA by the labeler of this product Gvs Tm Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Intended Use Of The Device
Intended for use only with automated red cell washing devices
and automated red cell apheresis devices.
I Intended for use only with automated red cell apheresis devices.
Storage And Handling
Store at room temperature (25 °C/77 °F). Avoid excessive heat.
Protect from freezing
Store at room temperature (25 °C/77 °F). Avoid excessive heat.
Protect from freezing.
Warnings And Precoutions Section
See appropriate Operator’s Manual for additional information and complete usage instructions.
Not for direct intravenous infusion
Do not use unless solution is clear and no leaks detected
Single use container. Discard unused portion
Intended for use only with automated red cell washing and apheresis devices
Store at room temperature. Avoid excessive heat. Protect from freezing
Description
ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 mL
Each 100 mL contains:
Citric Acid (Monohydrate), USP 0.042 g
Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g
Sodium Chloride, USP 0.410 g
Adenine, USP 0.030 g
Dextrose (Anhydrous), USP 1.000 g
Sodium Citrate (Dihydrate), USP 0.588 g
containing 15 mEq of Sodium.
.
Statement Of Identity
ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 ml
Warnings And Precoutions
Not for direct intravenous infusion
Do not use unless solution is clear and no leaks detected
Single use container. Discard unused portion
Intended for use only with automated red cell washing and apheresis devices
See Operator’s Manual for additional information and complete usage instructions
Store at room temperature. Avoid excessive heat. Protect from freezing
Description Of The Product
ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL
Each 100 mL contains:
Citric Acid (Monohydrate), USP 0.042 g
Monobasic Sodium Phosphate (Monohydrate), USP 0.042 g
Sodium Chloride, USP 0.410 g
Adenine, USP 0.030 g
Dextrose (Anhydrous), USP 1.000 g
Sodium Citrate (Dihydrate), USP 0.588 g
containing 15 mEq of Sodium.
Statement Of Idenity
ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL
Package Label
Manufacturer: GVS TM Inc.
1630 W Industrial Park St
Covina, CA 91722, USA
ADDITIVE SOLUTION FORMULA 3 (AS-3), 300 mL
Intended for use only with automated red cell washing devices
and automated red cell apheresis devices. See appropriate
Operator’s Manual for additional information and complete usage
instructions.
Each 100 mL contains:
Citric Acid (Monohydrate), USP 0.042 g
Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g
Sodium Chloride, USP 0.410 g
Adenine, USP 0.030 g
Dextrose (Anhydrous), USP 1.000 g
Sodium Citrate (Dihydrate), USP 0.588 g
containing 15 mEq of Sodium.
CAUTION: Refer to package insert. Not for direct intravenous
infusion. The pouch is a moisture barrier. Do not use unless
solution is clear and no leaks detected. Single use container.
Discard unused portion. Sterile, nonpyrogenic fluid path.
Sterilized by steam. Rx Only.
Store at room temperature (25 °C/77 °F). Avoid excessive heat.
Protect from freezing.
REF symbol: 0462A-00
LOT symbol
expiry date symbol
template revision number: 126618-00 REV.0
Manufacturer: GVS TM Inc.
1630 W Industrial Park St
Covina, CA 91722, USA
ADDITIVE SOLUTION FORMULA 3 (AS-3), 250 mL
Intended for use only with automated red cell apheresis devices. See appropriate
Operator’s Manual for additional information and complete usage
instructions.
Each 100 mL contains:
Citric Acid (Monohydrate), USP 0.042 g
Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g
Sodium Chloride, USP 0.410 g
Adenine, USP 0.030 g
Dextrose (Anhydrous), USP 1.000 g
Sodium Citrate (Dihydrate), USP 0.588 g
containing 15 mEq of Sodium.
CAUTION: Refer to package insert. Not for direct intravenous
infusion. The pouch is a moisture barrier. Do not use unless
solution is clear and no leaks detected. Single use container.
Discard unused portion. Sterile, nonpyrogenic fluid path.
Sterilized by steam. Rx Only.
Store at room temperature (25 °C/77 °F). Avoid excessive heat.
Protect from freezing.
REF symbol: 0460A-00
LOT symbol
expiry date symbol
template revision number 126617-00 REV.0
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