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
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
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 |
|---|
| 05060453480007 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05060453480007 | 05060453480007 | 5060453480007 |
GMDN Terms
| Term | Definition |
|---|
| Pharyngeal electrical stimulation catheter | A 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 | Condition |
|---|
| 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
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- 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 |
|---|
| 05060453480045 | Phagenyx | EPSB3 | EPSB3 | 2023-08-03 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 05060453480045 | Phagenyx | PHAGENESIS LIMITED | QQG | 2023-08-03 |
phagenesis.com