FDA UDI
In Commercial Distribution
🇺🇸 United States
PureDefense Surgical Mask
DI: 00851328007246
·
Model: VQN0185B
·
MEDIVISION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PureDefense Surgical Mask
- Primary DI
- 00851328007246
- Version / Model
- VQN0185B
- Catalog Number
- VQN0185B
- Company Name
- MEDIVISION, INC.
- Labeler DUNS
- 942192550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-12
- Public Version
- 1
- Public Version Date
- 2020-05-20
- Public Version Status
- New
- Public Device Record Key
- 6ca163ca-c10c-4c75-84de-efeddb95dc13
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FXX | Mask, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35177 | Surgical/medical face mask, single-use | A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851328007246 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173062 | 000 |