EXCOR® VAD

GUDID 04260090040225

Stationary Driving Unit Ikus Rev. 2.1

Berlin Heart GmbH

External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system External ventricular circulatory assist system
Primary Device ID04260090040225
NIH Device Record Key0ad2920e-9768-4958-990f-5a32b72d19b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXCOR® VAD
Version Model NumberD03I-111
Company DUNS328654384
Company NameBerlin Heart GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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

Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com
Phone1.281.863.9700
Emailinfo@berlinheartinc.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260090040225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSQVentricular (Assisst) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-20
Device Publish Date2014-09-24

On-Brand Devices [EXCOR® VAD]

04260090041086Manual pump
04260090041055Tank unit
04260090040409Arterial cannula for infans
04260090041369Arterial cannula for infants
04260090041352Arterial cannula for small children
04260090041338Arterial cannula for children
04260090041321Arterial cannula
04260090041307Atrial cannula
04260090041291Atrial cannula
04260090041284Atrial Cannula
04260090041277Atrial cannula for small children
04260090040607Connecting set for cannulas
04260090040591Connecting set for cannulas
04260090040577Driving tube, blue
04260090040560Driving tube, red
04260090040553Accessory set PU valves
04260090040539Apex cannula for infants
04260090040515Apex cannula for small children
04260090040508Arterial Cannula
04260090040492Apex cannula for children
04260090040461Atrial cannula for small children
04260090040430Atrial cannula for children
04260090040423Atrial cannula for children
04260090040393Arterial cannula for small children
04260090040386Arterial cannula for children
04260090040379Atrial cannula for infants
04260090040348Arterial cannula for children
04260090040331Arterial cannula for children
04260090040287Apex cannula one-part
04260090040256Atrial cannula
04260090040249Cannula extension set
04260090040232Atrial cannula
04260090040225Stationary Driving Unit Ikus Rev. 2.1
04260090040188Arterial cannula
04260090040171Cannula extension set
04260090040164Arterial cannula
04260090040157Blood pump PU valves; 15ml
04260090040140Cannula extension set
04260090040126Blood pump PU valves; 30ml
04260090040119Blood pump PU valves; 25ml
04260090040102Blood pump PU valves; 10ml
04260090040027Blood pump PU valves; 60ml
04260090040010Blood pump PU valves; 50ml

Trademark Results [EXCOR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXCOR
EXCOR
87473184 5390200 Live/Registered
NORTHERN TECHNOLOGIES INTERNATIONAL CORPORATION
2017-06-02
EXCOR
EXCOR
78159509 2740522 Live/Registered
Berlin Heart GmbH
2002-08-30
EXCOR
EXCOR
76249847 2828914 Dead/Cancelled
BERLIN HEART AG
2001-05-02
EXCOR
EXCOR
76161290 3015836 Live/Registered
NORTHERN TECHNOLOGIES INTERNATIONAL CORPORATION
2000-11-07
EXCOR
EXCOR
74470776 1865664 Dead/Cancelled
METHODE ELECTRONICS, INC.
1993-12-17
EXCOR
EXCOR
74218533 not registered Dead/Abandoned
ROGERS CORPORATION
1991-11-04

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