FDA.reportPublic FDA data

Avery Breathing Pacemaker System

Primary DI
00850252006066
Brand
Avery Breathing Pacemaker System
Company
Avery Biomedical Devices Inc
Model
NeurostimulatorTransmitter Digital
Catalog number
Spirit
Device description
Digital Transmitter for the Avery Breathing Pacemaker System
Published
2019-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZEImplanted Diaphragmatic/Phrenic Nerve Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZEImplanted Diaphragmatic/Phrenic Nerve StimulatorNeurology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P860026009

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P860026009DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATORAvery Biomedical Devices, Inc.1987-01-05GZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850252006066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850252006066008502520060668502520060660850252006066

GMDN Terms#

Term, Definition table
TermDefinition
Extramuscular diaphragm/phrenic nerve electrical stimulation systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
631-864-1600info@averybiomedical.com

Regulatory Flags#

DUNS number
064726441
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850252006059Avery Breathing Pacemaker SystemTranstelephonic MonitorTTM2015-01-23
00850252006004Avery Breathing Pacemaker SystemNeurostimulator Transmitter MARK IV2015-01-23
00850252006011Avery Breathing Pacemaker SystemNeurostimulator Receiver Implant I-110A2015-01-23
00850252006028Avery Breathing Pacemaker SystemNeurostimulator Electrode Implant E377-052015-01-23
00850252006035Avery Breathing Pacemaker SystemExternal Antenna 902A2015-01-23
00850252006042Avery Breathing Pacemaker SystemExternal Antenna902AL2015-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850252006004Avery Breathing Pacemaker SystemAvery Biomedical Devices IncGZE2015-01-23
00850252006011Avery Breathing Pacemaker SystemAvery Biomedical Devices IncGZE2015-01-23
00850252006028Avery Breathing Pacemaker SystemAvery Biomedical Devices IncGZE2015-01-23
00850252006035Avery Breathing Pacemaker SystemAvery Biomedical Devices IncGZE2015-01-23
00850252006042Avery Breathing Pacemaker SystemAvery Biomedical Devices IncGZE2015-01-23
00850252006059Avery Breathing Pacemaker SystemAvery Biomedical Devices IncGZE2015-01-23