DEVICE: EXCOR® (04260090041055)

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Device Record History
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Device Identifier (DI) Information
EXCOR®
1600190
In Commercial Distribution

Berlin Heart GmbH
04260090041055
GS1

1
328654384 *Terms of Use
Tank unit
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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 008
H100004 013
H100004 021
P160035 000
P160035 016
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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
2115dbdf-d4ea-4fea-88ef-18593491e5ae
August 20, 2024
6
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
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Customer Contact

[?]
1.281.863.9700
info@berlinheartinc.com
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