4B7870

GUDID 60085412081900

1.6% Sodium Chloride Processing Solution, 1000 mL

BAXTER INTERNATIONAL INC.

Blood cell freeze/thaw system
Primary Device ID60085412081900
NIH Device Record Key72adfde1-4d9c-4baa-9bd4-321e0c1e22a1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number4B7870
Catalog Number4B7870
Company DUNS005146311
Company NameBAXTER INTERNATIONAL INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended Strorage - Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing.
Storage Environment TemperatureBetween 25 Degrees Celsius and 0

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412081908 [Primary]
GS160085412081900 [Package]
Contains: 00085412081908
Package: CASE [14 Units]
In Commercial Distribution

FDA Product Code

KSWSYSTEM, PROCESSING FOR FROZEN BLOOD

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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