DEVICE: CLEARLINK/DUO-VENT (00085412048499)

Device Identifier (DI) Information

CLEARLINK/DUO-VENT
2H8480
In Commercial Distribution
2H8480
BAXTER INTERNATIONAL INC.
00085412048499
GS1

1
005146311 *Terms of Use
Non-DEHP Solution Set with DUO-VENT Spike, 0.2 Micron Downstream Filter, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar
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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 line filter A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FPA Set, administration, intravascular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153158 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

5beb0d37-bbd3-46a6-98d6-3af250f8ed4b
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
50085412048494 48 00085412048499 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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