AccessGUDID - DEVICE: Impella (04260113630327)

GUDID

Device Identifier (DI) Information

Brand Name: Impella
Version or Model: 0052-3018
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0052-3018
Company Name: Abiomed, Inc.

Primary DI Number: 04260113630327
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050636737 *Terms of Use

Device Description: Lake Region 0.027" PTFE Guidewire

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56732	Intracardiac circulatory assist axial-pump catheter	A sterile tubular device with a built-in electrically-powered axial flow pump (e.g., a micro motor with an impeller) at the distal end, designed to provide circulatory assistance to the heart by pumping blood during heart failure. It is inserted through the lumen of the aorta and into the left ventricle, surgically or percutaneously via an artery, and connected to an external control unit; it moves blood from the left ventricle to the aorta across the aortic valve. It is typically used emergently post acute myocardial infarction (AMI), electively for high-risk cardiac catheterization, for open chest surgery, and during transport between hospitals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZD	Temporary Non-Roller Type Left Heart Support Blood Pump
DQX	Wire, Guide, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 02259baa-c640-47fe-8759-463c0b62c24f
Public Version Date: May 05, 2023
Public Version Number: 4
DI Record Publish Date: October 21, 2016

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

Secondary DI

[?]

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

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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