FDA.reportPublic FDA data

Phagenyx

Primary DI
05060453480045
Brand
Phagenyx
Company
PHAGENESIS LIMITED
Model
EPSB3
Catalog number
EPSB3
Device description
Phagenyx Dysphagia Treatment Device
Published
2023-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QQGOropharyngeal Electrical Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQGOropharyngeal Electrical StimulatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220025000Phagenyx SystemPhagenesis Limited2022-09-16QQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060453480045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060453480045050604534800455060453480045

GMDN Terms#

Term, Definition table
TermDefinition
Pharyngeal electrical stimulation control unitA mains electricity (AC-powered) device, that includes internal rechargeable batteries, designed to treat neurogenic dysphagia by electrical stimulation of the nerves in the mucous membrane of the oropharynx, inducing compensatory reorganization of swallowing control in the central nervous system. It typically consists of a programmable pulse generator with user interface, connecting cables, and dedicated software. Electrical impulses are delivered via a single-patient nasogastric catheter.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3122888625support@phagenesis.com

Regulatory Flags#

DUNS number
210064003
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060453480007PhagenyxPNX-1000PNX-10002023-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060453480007PhagenyxPHAGENESIS LIMITEDQQG2023-08-03