AccessGUDID - DEVICE: OPTIMIZER™ (00810003380050)

GUDID

Device Identifier (DI) Information

Brand Name: OPTIMIZER™
Version or Model: CCM X10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-B411-3-XX
Company Name: Impulse Dynamics (usa) Inc.

Primary DI Number: 00810003380050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878519342 *Terms of Use

Device Description: OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug

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?
47468	Cardiac contractility modulation system pulse generator	A hermetically-sealed, battery-powered device implanted beneath the skin to produce electrical signals delivered to the heart via implantable cardiac pacing leads during the ventricular absolute refractory period (ARP) to enhance the strength of the heart [cardiac contractility modulation (CCM)], typically as treatment for heart failure. The device is programmed by and transmits cardiac diagnostic data to an external programmer telemetrically.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QFV	Implantable Pulse Generator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P180036	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
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c274906e-b972-472a-b8d6-8424446efb86
Public Version Date: January 05, 2021
Public Version Number: 1
DI Record Publish Date: December 28, 2020