DEVICE: EXACTAMIX (05413765477584)

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Device Identifier (DI) Information

EXACTAMIX
H9382400-DY
2400DY
BAXTER CORPORATION ENGLEWOOD
05413765477584
GS1
1
EXACTAMIX Compounder, EM2400 Display
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Intravenous solution compounder A device that is typically exclusively used in the clinical pharmacy or a manufacturing plant for the production of intravenous (IV) fluids. These fluids will typically be distributed using the appropriate containers.
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FDA Product Code

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Product Code Product Code Name
NEP SYSTEM/DEVICE, PHARMACY COMPOUNDING
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 32 and 147 Degrees Fahrenheit
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
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