WYZ Face Mask
- Primary DI
- 00860004437864
- Brand
- WYZ Face Mask
- Company
- Wyz Medical Supplies LLC
- Model
- 2111
- Device description
- ASTM LEVEL 1 FACE MASK BLUE
- Published
- 2021-01-18
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| LYU | Accessory, Surgical Apparel |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00860004437871 | Package | GS1 | 40 | Not in Commercial Distribution |
| 00860004437864 | Primary | GS1 | 0 | |
| 00860004437888 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00860004437871 | 00860004437871 | 860004437871 | 0860004437871 |
| 00860004437864 | 00860004437864 | 860004437864 | 0860004437864 |
| 00860004437888 | 00860004437888 | 860004437888 | 0860004437888 |
GMDN Terms#
| Term | Definition |
|---|---|
| Surgical/medical face mask, non-antimicrobial, 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). It does not include an antimicrobial/antiviral agent(s) and 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. This is a single-use device. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 0 Degrees Celsius | 40 Degrees Celsius | |
| Handling Environment Temperature | 0 Degrees Fahrenheit | 104 Degrees Fahrenheit |
Regulatory Flags#
- DUNS number
- 117528113
- Device count
- 50
- Premarket exempt
- true
- Lot or batch
- true
- Manufacturing date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00860004437833 | WYZ Face Mask | 2121 | 2021-01-09 | |
| 00860004437871 | WYZ Face Mask | 2111 | 2021-01-18 |
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