AccessGUDID - DEVICE: HVAD® Pump Implant Kit (Enhanced) (00888707000017)

GUDID

Device Identifier (DI) Information

Brand Name: HVAD® Pump Implant Kit (Enhanced)
Version or Model: 1103
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1103
Company Name: Heartware Inc.

Primary DI Number: 00888707000017
Issuing Agency: GS1
Commercial Distribution End Date: November 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 146054536 *Terms of Use

Device Description: No description.

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?
47533	Implantable ventricular circulatory assist system	A portable assembly of devices intended to provide mechanical assistance to a heart ventricle(s), typically by pumping blood from the left ventricle to the aorta through an extra-cardiac circuit. It includes an implantable pump(s), connecting cannula/graft(s), a percutaneous lead, and external components (e.g., battery pack, controller). It is typically intended to be used as a bridge to heart transplantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DSQ	Ventricular (Assisst) Bypass

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: 426f16aa-6f94-47a0-80b4-a6a62b026640
Public Version Date: July 16, 2024
Public Version Number: 4
DI Record Publish Date: August 13, 2014