DEVICE: UltraSet CAPD Disposable Disconnect Y-Set (00085412030579)

Device Identifier (DI) Information

UltraSet CAPD Disposable Disconnect Y-Set
5C4366P
In Commercial Distribution
5C4366P
BAXTER INTERNATIONAL INC.
00085412030579
GS1

10
005146311 *Terms of Use
The UltraSet products are single use devices that are intended for the drainage and infusion of peritoneal dialysis solution.
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Peritoneal dialysis system tubing set A sterile set intended for the administration of peritoneal dialysis. It will typically consist of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysis filter to trap and remove contaminating particles. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KDJ SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K961825 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

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Size Type Text
No Device Sizes
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Device Record Status

035c8509-2ea0-4536-8fe5-93e1c82f3fe0
July 06, 2018
3
October 07, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50085412030574 60 00085412030579 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

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Unit of Use DI Number: 90085412030572 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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