DEVICE: NA (00085412081915)
Device Identifier (DI) Information
NA
4B7877X
In Commercial Distribution
4B7877X
BAXTER HEALTHCARE CORPORATION
4B7877X
In Commercial Distribution
4B7877X
BAXTER HEALTHCARE CORPORATION
0.2% Dextrose and 0.9% Sodium Chloride Processing Solution, 1000 mL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45519 | Blood cell freeze/thaw system |
An assembly of devices designed for the automated processing of red blood cells received indirectly from a donor so that the cells can be safely frozen for storage in a closed, disposable set, and when needed, thawed for use. The assembly will typically add an appropriate substance (e.g., glycerol) to the blood cells to allow freezing, and facilitate the thawing process. The assembly may also wash the red blood cells to remove glycerol and plasma and extracellular components; it may also resuspend the cells in an additive solution. It will typically be comprised of pumps, a centrifuge, air detectors, a dedicated shaker, monitoring devices, disposable set, and possibly print-out facilities.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KSW | SYSTEM, PROCESSING FOR FROZEN BLOOD |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Recommended Storage - Room Temperature (25 Degrees Celsius). Avoid excessive heat. Protect from freezing. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cd2b752e-5431-46e2-8ddc-ba8f98592fce
June 26, 2025
8
September 24, 2016
June 26, 2025
8
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
50085412081910 | 14 | 00085412081915 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
Medinfo_medproducts@baxter.com