4B7877X

GUDID 50085412081910

0.2% Dextrose and 0.9% Sodium Chloride Processing Solution, 1000 mL

BAXTER INTERNATIONAL INC.

Blood cell freeze/thaw system

• Primary Device ID: 50085412081910
• NIH Device Record Key: cd2b752e-5431-46e2-8ddc-ba8f98592fce
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 4B7877X
• Catalog Number: 4B7877X
• Company DUNS: 005146311
• Company Name: BAXTER INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Recommended Strorage - Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing.
• Storage Environment Temperature: Between 25 Degrees Celsius and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412081915 [Primary]
GS1	50085412081910 [Package]; Contains: 00085412081915; Package: CASE [14 Units]; In Commercial Distribution

FDA Product Code

• KSW: SYSTEM, PROCESSING FOR FROZEN BLOOD

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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