AccessGUDID - DEVICE: Avery Breathing Pacemaker System (00850252006059)

GUDID

Device Identifier (DI) Information

Brand Name: Avery Breathing Pacemaker System
Version or Model: Transtelephonic Monitor
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TTM
Company Name: Avery Biomedical Devices Inc

Primary DI Number: 00850252006059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064726441 *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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Extramuscular diaphragm/phrenic nerve electrical stimulation system	An assembly of battery-powered devices designed to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve, to contract the diaphragm rhythmically and cause the patient to draw breath in a manner similar to natural breathing. It typically consists of an implanted receiver with electrodes that are placed around the patient's phrenic nerve, and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

GMDN Preferred Term Name

GMDN Definition

Extramuscular diaphragm/phrenic nerve electrical stimulation system

An assembly of battery-powered devices designed to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve, to contract the diaphragm rhythmically and cause the patient to draw breath in a manner similar to natural breathing. It typically consists of an implanted receiver with electrodes that are placed around the patient's phrenic nerve, and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

FDA Product Code

[?]

Product Code	Product Code Name
GZE	Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P860026	005

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: 2e50e793-2a2e-428a-8d3c-795d74fb637a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 23, 2015