DEVICE: EXACTAMIX (00085412482828)

Device Identifier (DI) Information

EXACTAMIX
H9381200-DYR
In Commercial Distribution
1200DYR
BAXTER CORPORATION ENGLEWOOD
00085412482828
GS1

1
078383477 *Terms of Use
EXACTAMIX Compounder, EM1200 Refurbished 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

[?]
Product Code Product Code Name
NEP SYSTEM/DEVICE, PHARMACY COMPOUNDING
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

74be1656-d42d-4fbf-a0c3-7c3432923de9
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
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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