DEVICE: EXACTAMIX (00085412480077)

Device Identifier (DI) Information

EXACTAMIX
H938711018
In Commercial Distribution
H938711018
BAXTER CORPORATION ENGLEWOOD
00085412480077
GS1

1
078383477 *Terms of Use
EXACTAMIX Connector, Tube Set Calibration Extension
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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
Intravenous administration tubing extension set A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
LHI Set, i.V. Fluid transfer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K900585 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
No Device Sizes
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Device Record Status

13c30a9f-5c73-4656-afc2-08db9fbc370a
July 06, 2018
3
September 24, 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
50085412480072 50 00085412480077 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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