DEVICE: Impella (00813502010985)

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Device Record History
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Device Identifier (DI) Information
Impella
0042-0010-US
In Commercial Distribution
0042-0010-US
Abiomed, Inc.
00813502010985
GS1

1
050636737 *Terms of Use
Impella Optical Controller, Packaged, US
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
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No

GMDN

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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?
57808 Intracardiac circulatory assist axial-pump catheter control unit
A mains electricity (AC-powered) device designed to operate and monitor an intracardiac circulatory assist axial-pump catheter (e.g., a catheter with integrated micro motor and impeller) to provide circulatory assistance to the heart by pumping blood during heart failure. It typically consists of operator controls, a monitoring interface, a low-voltage connection to drive the impeller, a fluid purging pump, and provides backup power when line power is not available during transport. It is typically used emergently [e.g., post acute myocardial infarction (AMI)] or electively when haemodynamic support is necessary.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OZD Temporary Non-Roller Type Left Heart Support Blood Pump
PYX Temporary Non-Roller Type Right Heart Support Blood Pump
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
3908cd5c-e9c6-4a82-a562-6ea49c1959f0
August 16, 2023
1
August 08, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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