AccessGUDID - DEVICE: OMNI™ II (00810003380012)

GUDID

Device Identifier (DI) Information

Brand Name: OMNI™ II
Version or Model: Programmer System (with OMNI Smart Software)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-A604-3-US
Company Name: Impulse Dynamics (usa) Inc.

Primary DI Number: 00810003380012
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878519342 *Terms of Use

Device Description: OMNI™ II Programmer System (with OMNI Smart Software). System consists of: (1) OMNI II Programmer (with OMNI Smart Software) (1) OMNI II Programmer Tablet PC installed with OMNI Smart Programmer Software (1) OMNI II Programmer Interface Box (1) OMNI II Programmer Interface Box Cable (1) Medical-grade Ethernet isolator with Ethernet patch cable (1) OMNI II Programmer Wand (1) OMNI II Programmer Wand Extension Cable (1) USB to Serial Adapter Assembly (1) Single-lead (3-wire) ECG cable (1) Medical-grade Power Supply (1) Medical-grade Power Cord (1) Bluetooth printer with AC Adapter (2) Bluetooth printer paper rolls

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:	No
Prescription Use (Rx):	No
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?
47467	Cardiac contractility modulation system programmer	A portable, battery-powered device used by healthcare personnel to telemetrically receive diagnostic data from and modify the cardiac contractility signal parameters of an implanted pulse generator of a cardiac contractility modulation (CCM) system.	Active	false

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c3d82dba-e3c9-4f38-a322-14725ced1b99
Public Version Date: December 24, 2020
Public Version Number: 2
DI Record Publish Date: April 12, 2019