FDA UDI
In Commercial Distribution
🇺🇸 United States
APEX
DI: 04713025000981
·
Model: WiZARD 320
·
Wellell Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- APEX
- Primary DI
- 04713025000981
- Version / Model
- WiZARD 320
- Company Name
- Wellell Inc.
- Labeler DUNS
- 656413127
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-15
- Public Version
- 1
- Public Version Date
- 2024-08-23
- Public Version Status
- New
- Public Device Record Key
- 0c567ba9-6777-42e3-9a65-312441f3fee2
Device Description
WiZARD 320 Full Face Mask(S/M/L)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57814 | CPAP/BPAP face mask, reusable | A flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04713025000981 | GS1 |