DEVICE: CLR1 - CLEARLINK (00085412676623)

Device Identifier (DI) Information

CLR1 - CLEARLINK
2R8402
In Commercial Distribution
2R8402
BAXTER INTERNATIONAL INC.
00085412676623
GS1

1
005146311 *Terms of Use
Non-DEHP Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 100” (2.5m) approx., 10 drops/mL approx.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58977 Basic intravenous administration set, noninvasive
A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.
Active false
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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 [?]
K180739 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
Length: 100 Inch
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Device Record Status

583b214d-f4d3-4d8d-88b1-6e46fc64eb24
July 24, 2023
1
July 14, 2023
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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
50085412676628 48 00085412676623 In Commercial Distribution CA
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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
US-MEDINFO_MEDPRODUCTS@baxter.com
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