DEVICE: EXCOR® VAD (04260090040157)

Device Identifier (DI) Information

EXCOR® VAD
P15P-001
In Commercial Distribution

Berlin Heart GmbH
04260090040157
GS1

1
328654384 *Terms of Use
Blood pump PU valves; 15ml
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Device Characteristics

MR Unsafe
No
No
Yes
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 010
H100004 012
H100004 013
H100004 014
H100004 017
H100004 020
H100004 021
P160035 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 35 and 50 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

e4044dc1-8143-4b45-ad84-d9a62e168c6b
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
Yes
No
No CLOSE

Customer Contact

[?]
1.281.863.9700
info@berlinheartinc.com
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