AccessGUDID - DEVICE: NeuRx DPS™ System Kit, Canada (00852184003243)

GUDID

Device Identifier (DI) Information

Brand Name: NeuRx DPS™ System Kit, Canada
Version or Model: 20-0032
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Synapse Biomedical, Inc.

Primary DI Number: 00852184003243
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 138432070 *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:	No
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?
47812	Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator	An external, battery-powered device designed to provide electrical signals (pulses), through implanted electrodes, to stimulate the phrenic nerve motor point in the diaphragm and contract the diaphragm rhythmically to cause a patient to draw breath in a manner similar to natural breathing. It is typically a small, body-worn, programmable device [an external pulse generator (EPG)] that is programmed by a healthcare professional; the programs can be altered remotely by telemetric communication with a clinical workstation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OIR	Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

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: No
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: def940ae-5697-4578-99d2-cfcb94c8aa28
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2014