Identity
- Trade Name
- PureDefense Surgical Mask FDA UDI
- Generic Name
- Surgical/medical face mask, single-use FDA UDI
- Device Name
- Non-woven face mask, with ties, intended for single use by operating room personnel and other general health care workers to protect patients and healthcare workers against the transfer of microorganisms, blood and body fluids, and particulate materials. FDA UDI
- Model / Reference
- VQN0185B FDA UDI
- Description
- Non-woven face mask, with ties, intended for single use by operating room personnel and other general health care workers to protect patients and healthcare workers against the transfer of microorganisms, blood and body fluids, and particulate materials. FDA UDI
Identifiers
- Catalog Number
- VQN0185B FDA UDI
- Primary DI / UDI-DI
- 00851328007246 FDA UDI
- 510(k) Number
- K173062 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical face mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical/medical face mask, single-use
PureDefense Surgical Mask by Medivision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medivision, Inc.
Sources (1)
- FDA UDI 6ca163ca-c10c-4c75-84de-efeddb95dc13 35 fields · synced May 30, 2026