DEVICE: Effluent Sample Bag (00085412007717)
Device Identifier (DI) Information
Effluent Sample Bag
5C4476
In Commercial Distribution
5C4476
BAXTER INTERNATIONAL INC.
5C4476
In Commercial Distribution
5C4476
BAXTER INTERNATIONAL INC.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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No | |
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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? |
---|---|---|---|---|
35000 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FKX | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K923065 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at Room Temperature |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e4faaf8b-3b92-4870-9a36-0156a0e55fb1
January 24, 2024
6
September 24, 2015
January 24, 2024
6
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
50085412007712 | 6 | 00085412007717 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
Medinfo_medproducts@baxter.com