FDA UDI
In Commercial Distribution
🇺🇸 United States
Phoenix Healthcare Solutions LLC
DI: 00360913523011
·
Model: PHX-SV-01
·
PHOENIX HEALTHCARE SOLUTIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phoenix Healthcare Solutions LLC
- Primary DI
- 00360913523011
- Version / Model
- PHX-SV-01
- Company Name
- PHOENIX HEALTHCARE SOLUTIONS, LLC
- Labeler DUNS
- 079146847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-11
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- aaaea884-c08b-499e-9697-31ef7e20c20d
Device Description
Steam Vaporizer
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | Anesthesiology | 868.5460 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63430 | Steam inhaler, electrically-powered | An electrically-powered, hand-held device designed for the inhalation of steam for the relief of the symptoms (congestion and pressure) associated with upper respiratory disorders. It consists of a water tank with integrated water heater and an attached mask/mouthpiece. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00360913523011 | GS1 |