DEVICE: xevonta (04046963926304)
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If so, send a picture of the label to
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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.
|
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 |
|---|
| 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