FDA UDI
In Commercial Distribution
🇺🇸 United States
Phagenyx
DI: 05060453480045
·
Model: EPSB3
·
PHAGENESIS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phagenyx
- Primary DI
- 05060453480045
- Version / Model
- EPSB3
- Catalog Number
- EPSB3
- Company Name
- PHAGENESIS LIMITED
- Labeler DUNS
- 210064003
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-03
- Public Version
- 1
- Public Version Date
- 2023-08-11
- Public Version Status
- New
- Public Device Record Key
- a1960e31-f381-4ec8-9df8-a4197e4da57f
Device Description
Phagenyx Dysphagia Treatment Device
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QQG | Oropharyngeal Electrical Stimulator | Ear, Nose, Throat | 874.5950 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060453480045 | GS1 |
Customer Contacts
- Phone
- 3122888625
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN220025 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal