DEVICE: CLEARLINK/DUO-VENT (00085412046389)

Device Identifier (DI) Information

CLEARLINK/DUO-VENT
2C8875
In Commercial Distribution
2C8875
BAXTER INTERNATIONAL INC.
00085412046389
GS1

1
005146311 *Terms of Use
Solution Set with DUO-VENT Spike, Polyethylene Lined Tubing, Non-DEHP Pump Segment, Luer Activated Valve, 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
Non-absorbing intravenous administration set A collection of sterile devices designed for the intravenous (IV) administration of solutions and manufactured with low-absorption plastics to avoid partial absorption of the components of the infused solutions. It typically consists of plastic tubes made of or lined with non absorbing plastics [e.g., polyethylene (PE), Teflon], to avoid solution contact with polyvinyl chloride (PVC) components; it also includes a check valve, a roller clamp, a Y-site connector, and Luer adaptors. The set is mainly used in high-flow infusion pumps for administration of solutions containing products (e.g., nitroglycerin) that are absorbed by PVC materials. 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 [?]
K112893 000
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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

5f8e1b77-c367-445b-a2ff-ce73c64a0cea
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
50085412046384 48 00085412046389 In Commercial Distribution CASE
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Secondary DI

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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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