DEVICE: Empty Sterile Container (00085412007670)

Device Identifier (DI) Information

Empty Sterile Container
5C4462
In Commercial Distribution
5C4462
BAXTER INTERNATIONAL INC.
00085412007670
GS1

1
005146311 *Terms of Use
This set is intended for use with a Baxter transfer set for peritoneal dialysis patients requiring a sterile container for drainage. (i.e. CCPD patients doing a daytime exchange or CAPD patients who have disconnected between exchanges).
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
FKX SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K833065 000
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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
Total Volume: 3 Liter
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Device Record Status

f8ceba36-7420-40d7-acc6-0c752d0a31b1
July 06, 2018
3
September 24, 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
50085412007675 48 00085412007670 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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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