FDA.reportPublic FDA data

Avery Breathing Pacemaker System

Primary DI
00850252006004
Brand
Avery Breathing Pacemaker System
Company
Avery Biomedical Devices Inc
Model
Neurostimulator Transmitter
Catalog number
MARK IV
Published
2015-01-23
Public version status
Update
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
P860026008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P860026008DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATORAvery Biomedical Devices, Inc.1987-01-05GZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850252006004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850252006004008502520060048502520060040850252006004

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
00850252006066Avery Breathing Pacemaker SystemNeurostimulatorTransmitter DigitalSpirit2019-11-08
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
00850252006066Avery Breathing Pacemaker SystemAvery Biomedical Devices IncGZE2019-11-08
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