AccessGUDID - DEVICE: Impella (00813502011180)

GUDID

Device Identifier (DI) Information

Brand Name: Impella
Version or Model: Impella 5.0 AIC Pump Set
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 005062
Company Name: Abiomed, Inc.

Primary DI Number: 00813502011180
Issuing Agency: GS1
Commercial Distribution End Date: October 04, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 050636737 *Terms of Use

Device Description: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

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:	Yes
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
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
OZD	Temporary Non-Roller Type Cardiac Support Blood Pump

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: 2f874fba-08ed-4b69-ad5c-0ae777c2f439
Public Version Date: April 28, 2023
Public Version Number: 3
DI Record Publish Date: July 31, 2014