FDA UDI
In Commercial Distribution
🇺🇸 United States
Perfetta Face Mask
DI: 08938504806038
·
Model: Moderate Blue
·
PHU BAO GROUP COMPANY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Perfetta Face Mask
- Primary DI
- 08938504806038
- Version / Model
- Moderate Blue
- Company Name
- PHU BAO GROUP COMPANY LIMITED
- Labeler DUNS
- 555240671
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-06-25
- Public Version
- 1
- Public Version Date
- 2020-07-03
- Public Version Status
- New
- Public Device Record Key
- f87514a4-dc3a-4b8b-8eca-53f60971524a
Device Description
3 Ply - Disposable High Filtration Face Mask Non-sterile, single use Color Blue 50 masks pack in one box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MSH | Respirator, 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 | 08938504806038 | GS1 | ||||
| Unit of Use | 89385048060382 | GS1 |