FDA.reportPublic FDA data

BioRef-DC

Primary DI
07290017249049
Brand
BioRef-DC
Company
TAVGER LTD
Model
FG00019
Device description
BIOFEEDBACK DEVICE BioRef-DC
Published
2022-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017249049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017249049072900172490497290017249049

GMDN Terms#

Term, Definition table
TermDefinition
Intramuscular 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 implanted intramuscular electrodes placed in the diaphragm in proximity to the phrenic nerve motor point, an external pulse generator (EPG), and a cable to connect the externally exposed ends of the electrodes with the EPG. The system typically controls parameters such as pulse amplitude, pulse duration, pulse frequency, inspiration time, and respiratory rate.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533284357
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017249032MesoStripFG000102022-03-24
07290017249056Affinity G.J.S with accessories FG000142022-03-24
07290017249063Affinity Home with accessories FG000162022-03-24
07290017249070Handpiece Affinity G.J.SFG000222022-03-24
07290017249001Affinity with accessoriesFG000042017-07-07
07290017249018Disposable tips boxFG000062017-07-07
07290017249002Disposable tips boxAFHP250012017-07-07

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