FDA UDI
In Commercial Distribution
🇺🇸 United States
Phagenyx
DI: 05060453480007
·
Model: PNX-1000
·
PHAGENESIS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phagenyx
- Primary DI
- 05060453480007
- Version / Model
- PNX-1000
- Catalog Number
- PNX-1000
- 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
- 668fb13c-15ef-407c-a521-1480f4bb49e5
Device Description
Phagenyx dysphagia treatment device
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 60946 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060453480007 | 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