DEVICE: SynCardia Companion Driver Caddy (00858000003145)

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Device Record History
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Device Identifier (DI) Information
SynCardia Companion Driver Caddy
397001-001
In Commercial Distribution

SYNCARDIA SYSTEMS, LLC
00858000003145
GS1

1
080414145 *Terms of Use
No description.
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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?
63640 Ventricular prosthesis system, pneumatically-powered
An assembly of devices intended to function as an artificial replacement for failing heart ventricles (end-stage biventricular failure), typically temporarily prior to heart transplantation. It consists of two implanted pneumatically-powered pumping units, with built-in mechanical heart valves, which replace the excised natural heart ventricles and are connected to the heart atria, aorta, and pulmonary arteries; the prosthesis is driven by an external pneumatic pump connected via percutaneous pneumatic drive-lines entering the patient's chest.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LOZ Artificial Heart
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P030011 011
P030011 013
P030011 015
P030011 022
P030011 023
P030011 027
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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 Temperature: between 4.5 and 40 Degrees Celsius
Storage Environment Temperature: between 4.5 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
0b86fbbd-3636-4f88-8120-33d800b31156
June 06, 2025
1
May 29, 2025
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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

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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

[?]
No Customer Contact currently defined
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