DEVICE: EXCOR® VAD (04260090040010)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
EXCOR® VAD
P50P-001
In Commercial Distribution

Berlin Heart GmbH
04260090040010
GS1

1
328654384 *Terms of Use
Blood pump PU valves; 50ml
CLOSE

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 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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DSQ Ventricular (Assisst) Bypass
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
H100004 003
H100004 004
H100004 006
H100004 008
H100004 010
H100004 012
H100004 013
H100004 014
H100004 017
H100004 020
H100004 021
P160035 000
P160035 001
P160035 003
P160035 004
P160035 007
P160035 009
P160035 010
P160035 011
P160035 013
P160035 014
P160035 016
P160035 017
P160035 019
P160035 021
P160035 023
P160035 024
P160035 027
P160035 030
P160035 034
P160035 035
P160035 036
P160035 037
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

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
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
66b74ab6-7b37-4465-8d1a-eeda9ed22573
April 04, 2024
8
September 24, 2014
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
1.281.863.9700
info@berlinheartinc.com
CLOSE