DEVICE: Polyflux (07332414048181)

Device Identifier (DI) Information

Polyflux
21L
In Commercial Distribution
104176
Gambro Dialysatoren GmbH
07332414048181
GS1

1
316150549 *Terms of Use
The Polyflux L is intended for use in haemodialysis for the treatment of chronic or acute renal failure
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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
Hollow-fibre haemodialysis dialyser, single-use A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FJI DIALYZER, CAPILLARY, HOLLOW FIBER
MSF HEMODIALYZER, RE-USE, HIGH FLUX
KDI Dialyzer, high permeability with or without sealed dialysate system
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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
Handling Environment Temperature: less than 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

bb5f947c-b7ca-46e1-a83f-3d6cff1d6db8
March 29, 2018
2
October 12, 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
37332414048182 24 07332414048181 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
No
No CLOSE

Customer Contact

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