FDA UDI
In Commercial Distribution
🇺🇸 United States
APEX
DI: 04713025001872
·
Model: WiZARD 510
·
Wellell Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- APEX
- Primary DI
- 04713025001872
- Version / Model
- WiZARD 510
- Company Name
- Wellell Inc.
- Labeler DUNS
- 656413127
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-11
- Public Version
- 3
- Public Version Date
- 2024-06-28
- Public Version Status
- Update
- Public Device Record Key
- 41b91347-5d79-489d-917a-a99a38554b73
Device Description
WiZARD 510 Nasal Mask M Size
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 57815 | CPAP/BPAP nasal mask, reusable | A flexible, form-shaped device designed to be placed over a user's nose 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. 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 | 04713025001872 | GS1 | ||||
| Package | 14713025001879 | GS1 | 60 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193206 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -15 – 60 Degrees Celsius