DEVICE: EXCOR® (04260090041277)

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Device Record History
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Device Identifier (DI) Information
EXCOR®
C19V-020m
In Commercial Distribution

Berlin Heart GmbH
04260090041277
GS1

1
328654384 *Terms of Use
Atrial cannula for small children Ø 6 mm; L 25 cm; head 14 mm
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Device Characteristics
MR Unsafe
No
No
Yes
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 [?]
P160035 002
P160035 004
P160035 011
P160035 016
P160035 019
P160035 024
P160035 032
P160035 037
No CLOSE

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

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

[?]
Size Type Text
Lumen/Inner Diameter: 6 Millimeter
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Device Record Status
35f09e44-295b-4bfa-9a04-69ac6ca446d1
August 20, 2024
10
September 06, 2017
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1.281.863.9700
info@berlinheartinc.com
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