AccessGUDID - DEVICE: Phagenyx (05060453480045)

GUDID

Device Identifier (DI) Information

Brand Name: Phagenyx
Version or Model: EPSB3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EPSB3
Company Name: PHAGENESIS LIMITED

Primary DI Number: 05060453480045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 210064003 *Terms of Use

Device Description: Phagenyx Dysphagia Treatment Device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60945	Pharyngeal electrical stimulation control unit	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QQG	Oropharyngeal Electrical Stimulator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN220025	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1960e31-f381-4ec8-9df8-a4197e4da57f
Public Version Date: May 01, 2025
Public Version Number: 2
DI Record Publish Date: August 03, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 3122888625
Email: support@phagenesis.com

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