PremierPro
- Primary DI
- 10811220032330
- Brand
- PremierPro
- Company
- SVS LLC
- Model
- 2486
- Device description
- Cone Style N95 Mask, Universal, NIOSH
- Published
- 2020-04-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| MSH | Respirator, Surgical |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MSH | Respirator, Surgical | General, Plastic Surgery | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10811220032330 | Package | GS1 | 12 | In Commercial Distribution |
| 00811220032333 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10811220032330 | 10811220032330 | | |
| 00811220032333 | 00811220032333 | 811220032333 | 0811220032333 |
GMDN Terms
| Term | Definition |
|---|
| Surgical/medical respirator, single-use | A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) during medical, surgical, dental, and isolation procedures. It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device. |
Regulatory Flags
- DUNS number
- 831375089
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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