AccessGUDID - DEVICE: Impella (00813502011401)

GUDID

Device Identifier (DI) Information

Brand Name: Impella
Version or Model: 0042-0040-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0042-0040-US
Company Name: Abiomed, Inc.

Primary DI Number: 00813502011401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050636737 *Terms of Use

Device Description: Optical, AIC, Impella Connect, Pkgd, US

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?
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

FDA Product Code

[?]

Product Code	Product Code Name
PYX	Temporary Non-Roller Type Right Heart Support Blood Pump
OZD	Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P140003	000
P170011	000

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: c0a0139f-49cf-4086-90d5-3980625aa03b
Public Version Date: August 08, 2023
Public Version Number: 1
DI Record Publish Date: July 31, 2023

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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