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
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| QQG | Oropharyngeal Electrical Stimulator |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QQG | Oropharyngeal Electrical Stimulator | Ear, Nose, Throat | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| DEN220025 | 000 | Phagenyx System | Phagenesis Limited | 2022-09-16 | QQG |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05060453480045 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05060453480045 | 05060453480045 | 5060453480045 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Atmospheric Pressure | 50 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 20 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 10 Degrees Celsius | 30 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 210064003
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 05060453480007 | Phagenyx | PNX-1000 | PNX-1000 | 2023-08-03 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 05060453480007 | Phagenyx | PHAGENESIS LIMITED | QQG | 2023-08-03 |
phagenesis.com