DEVICE: EXCOR® (04260090040225)

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Device Record History
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Device Identifier (DI) Information
EXCOR®
D03I-111
In Commercial Distribution

Berlin Heart GmbH
04260090040225
GS1

1
328654384 *Terms of Use
Stationary Driving Unit Ikus Rev. 2.1
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Device Characteristics
MR Unsafe
No
No
No
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?
10847 External ventricular circulatory assist system
An assembly of devices intended to assist a damaged or weakened heart (e.g., one affected by cardiogenic shock) to pump blood. It includes a electrically-powered external pump, an atrial or ventricular cannula to draw blood outside the body, a cannula to deliver the blood back to the aorta or pulmonary artery (depending on left or right ventricular assistance), and a unit that controls pump operation. It is typically intended to be used as a bridge to heart transplantation; it is not intended for cardiopulmonary bypass.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DSQ Ventricular (Assisst) Bypass
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
H100004 003
H100004 004
H100004 006
H100004 007
H100004 008
H100004 009
H100004 013
H100004 016
H100004 021
P160035 000
P160035 001
P160035 005
P160035 006
P160035 008
P160035 012
P160035 015
P160035 016
P160035 020
P160035 022
P160035 026
P160035 028
P160035 038
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 45 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 78 and 101 KiloPascal
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Handling Environment Temperature: between 10 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
0ad2920e-9768-4958-990f-5a32b72d19b9
August 20, 2024
9
September 24, 2014
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
1.281.863.9700
info@berlinheartinc.com
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