DEVICE: NA (00085412004778)

Device Identifier (DI) Information

NA
2N3342
In Commercial Distribution
2N3342
BAXTER INTERNATIONAL INC.
00085412004778
GS1

1
005146311 *Terms of Use
Non-DEHP Three Lead Catheter Extension Set, 0.22 Micron Filter, Male Luer Lock Adapter
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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
FPB Filter, infusion line
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K113227 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

a0387431-e50e-437b-bb92-9a0a0d08f3dc
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
50085412004773 50 00085412004778 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
No
No
No CLOSE

Customer Contact

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