FDA.reportPublic FDA data

Avery Breathing Pacemaker System

Primary DI
00850252006028
Brand
Avery Breathing Pacemaker System
Company
Avery Biomedical Devices Inc
Model
Neurostimulator Electrode Implant
Catalog number
E377-05
Published
2015-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
P860026006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P860026006DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATORAvery Biomedical Devices, Inc.1987-01-05GZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850252006028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850252006028008502520060288502520060280850252006028

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
064726441
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850252006059Avery Breathing Pacemaker SystemTranstelephonic MonitorTTM2015-01-23
00850252006066Avery Breathing Pacemaker SystemNeurostimulatorTransmitter DigitalSpirit2019-11-08
00850252006004Avery Breathing Pacemaker SystemNeurostimulator Transmitter MARK IV2015-01-23
00850252006011Avery Breathing Pacemaker SystemNeurostimulator Receiver Implant I-110A2015-01-23
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
00850252006066Avery Breathing Pacemaker SystemAvery Biomedical Devices IncGZE2019-11-08
00850252006004Avery Breathing Pacemaker SystemAvery Biomedical Devices IncGZE2015-01-23
00850252006011Avery 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