DEVICE: Locking Titanium Adapter for Peritoneal Dialysis Catheter (00085412007403)

Device Identifier (DI) Information

Locking Titanium Adapter for Peritoneal Dialysis Catheter
5C4129
In Commercial Distribution
5C4129
BAXTER INTERNATIONAL INC.
00085412007403
GS1

1
005146311 *Terms of Use
This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector. The adapter is used to connect the PD catheter to a solution transfer set with locking connector.
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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 catheter adaptor, single-use A connecting device, often in two pieces, intended to be used to join a peritoneal dialysis catheter to the dialysate line during treatment. It is typically made of plastic or metal and may be used when the devices to be connected are from different manufacturers and not compatible, enabling them to mate, and/or within a mechanical connection system. 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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store at room temperature
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d45e3ef9-955b-4a4a-8801-6d4e7a8bcaa7
March 29, 2018
2
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
50085412007408 5 00085412007403 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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