DEVICE: EXCOR® VAD (04260090040225)

Device Identifier (DI) Information

EXCOR® VAD
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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 mains electricity (AC-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.
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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
No CLOSE

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
July 06, 2018
3
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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