DEVICE: Impella (00813502011135)

Device Identifier (DI) Information

Impella
0043-0003
In Commercial Distribution
0043-0003
Abiomed, Inc.
00813502011135
GS1

5
050636737 *Terms of Use
Purge Cassette, 5 Pack
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Device Characteristics

Labeling does not contain MRI Safety Information
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?
57791 Infusion pump cassette
A sterile device designed to be used in conjunction with an infusion pump or a device containing an infusion pump (e.g., a physiology-monitoring sedation system, physiology-monitoring anaesthesia system), for the delivery of an intravenous (IV) medication (e.g., a sedative or anaesthetic) contained within an independent drug vial. The cassette is inserted into the infusion pump and the drug vial is inserted into the cassette; the cassette tubing interfaces with the pump drive mechanism for medication delivery through connection with an infusion administration set. This is a single-use device.
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 [?]
P140003 000
P170011 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ddd5664c-0e26-4bc4-aef8-60c28110d9db
June 20, 2023
5
July 31, 2014
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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: 00813502010510 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
978.777.5410
wbolt@abiomed.com
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