DEVICE: EXACTAMIX (00085412477473)

Device Identifier (DI) Information

EXACTAMIX
H938905
In Commercial Distribution
H938905
BAXTER CORPORATION ENGLEWOOD
00085412477473
GS1

1
078383477 *Terms of Use
EXACTAMIX EVA - Dual Chamber Empty Container
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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
Parenteral/enteral solution bag A flexible pouch or sack designed to contain a solution of nutrients or medication for administration to a patient either parenterally (e.g., intravenously) or enterally (directly into the gastrointestinal tract). It is typically made of synthetic polymer materials. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
KPE CONTAINER, I.V.
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K960581 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 3000 Milliliter
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Device Record Status

513dc067-90be-4366-b83d-bd26cc05b7a6
July 06, 2018
3
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
50085412477478 42 00085412477473 In Commercial Distribution CASE
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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