DEVICE: SynCardia temporary Total Artificial Heart System (00858000003008)

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Device Identifier (DI) Information

SynCardia temporary Total Artificial Heart System
500101-001

SYNCARDIA SYSTEMS, LLC
00858000003008
GS1
1
No description.
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Artificial heart, temporary A sterile prosthetic device implanted in the thorax or abdomen that typically consists of an implantable metallic and plastic mechanism that includes one or more pumps working as artificial ventricles to circulate blood, and an electrical or air driven external power unit that is connected to the pumps through transcutaneous electrical wires or pneumatic drive-lines entering the patient's chest. The power unit is attached to the patient and includes a battery and/or a pneumatic console. This device is used mostly as a bridge to heart transplantation.
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FDA Product Code

[?]
Product Code Product Code Name
LOZ Artificial Heart
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 20 and 27 Degrees Celsius
Handling Environment Temperature: between 20 and 27 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Total Volume: 70 Cubic Centimeter
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Device Status

In Commercial Distribution
October 23, 2015

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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
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
8667719437
xx@xx.xx
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