DEVICE: xevonta (04046963926304)
Device Identifier (DI) Information
xevonta
7204405
In Commercial Distribution
7204405
B.Braun Avitum AG
7204405
In Commercial Distribution
7204405
B.Braun Avitum AG
XEVONTA DIALYZER HI 23 US, GAMMA
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
47072 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KDI | Dialyzer, high permeability with or without sealed dialysate system |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 0 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Max TMP (kPa) : 80.000 KPA |
Device Size Text, specify: Max TMP (mmHg) : 600.000 MHG |
Device Size Text, specify: Surface (m²) : 2.300 M2 |
Device Record Status
bda9603a-6066-46ad-88a2-fef1a1a4b403
April 23, 2021
6
August 19, 2016
April 23, 2021
6
August 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04046963926298
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
BBMUS_Service.EmailOrders@bbraun.com