Dialog+® 710200S

GUDID 04046964285608

Dialog + 120 V DF+Adimea+WAN-BSL+BIC

B.Braun Avitum AG

Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional
Primary Device ID04046964285608
NIH Device Record Key9f119f16-1a87-40c0-b0ea-97bfd7d9c051
Commercial Distribution StatusIn Commercial Distribution
Brand NameDialog+®
Version Model Number710200S
Catalog Number710200S
Company DUNS343689704
Company NameB.Braun Avitum AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com
Phone+1(800)848-2066
Emailrtd.us@bbraun.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964285608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDIDialyzer, high permeability with or without sealed dialysate system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-14
Device Publish Date2015-08-09

On-Brand Devices [Dialog+®]

04046964285615Dialog + 120 V DF+Adimea+WAN-BSL
04046964285608Dialog + 120 V DF+Adimea+WAN-BSL+BIC
04046963686345Dialog+® Hemodialysis System with BIC Holder for Bicarbonate Cartridge
04046963686338Dialog+® Evolution Hemodialysis System

Trademark Results [Dialog+]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIALOG+
DIALOG+
76567692 3097064 Live/Registered
B. BRAUN AVITUM AG
2003-12-12

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