DEVICE: Effluent Sample Bag (00085412007717)

Device Identifier (DI) Information

Effluent Sample Bag
5C4476
In Commercial Distribution
5C4476
BAXTER INTERNATIONAL INC.
00085412007717
GS1

1
005146311 *Terms of Use
This bag is intended to collect sample drainage of peritoneal dialysis effluent from Baxter Peritoneal Dialysis Tubing Sets and is intended for use with Luer connector products.
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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 [?]
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

e4faaf8b-3b92-4870-9a36-0156a0e55fb1
March 29, 2018
2
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
50085412007712 6 00085412007717 In Commercial Distribution CASE
80085412007713 108 50085412007712 In Commercial Distribution CARTON
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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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