FDA.reportPublic FDA data

Phagenyx

Primary DI
05060453480007
Brand
Phagenyx
Company
PHAGENESIS LIMITED
Model
PNX-1000
Catalog number
PNX-1000
Device description
Phagenyx dysphagia treatment device
Published
2023-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

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
05060453480007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060453480007050604534800075060453480007

GMDN Terms#

Term, Definition table
TermDefinition
Pharyngeal electrical stimulation catheterA sterile, flexible tubular device intended to deliver pharyngeal electrical stimulation for the treatment of neurogenic dysphagia. Electrical impulses from a dedicated control unit are delivered through electrodes on the surface of a specialized enteral feeding tube, which is positioned so that the electrodes are in contact with the mucous membrane of the oropharynx. The catheter may have additional electronics e.g., for storing product, patient and treatment information. This is a single-patient device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060453480045PhagenyxEPSB3EPSB32023-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060453480045PhagenyxPHAGENESIS LIMITEDQQG2023-08-03