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.
As-3 Solution
FDA Label NDC 87069-460
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gvs Tm Inc for the product As-3 (NDC 87069-460). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding intended use of the device, storage and handling, warnings and precoutions section, description, statement of identity, warnings and precoutions, description of the product, statement of idenity, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
