FDA UDI
In Commercial Distribution
🇺🇸 United States
ProGear/Oxafence
DI: 00852212003719
·
Model: AV82030
·
PRESTIGE AMERITECH, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- ProGear/Oxafence
- Primary DI
- 00852212003719
- Version / Model
- AV82030
- Company Name
- PRESTIGE AMERITECH, LTD.
- Labeler DUNS
- 199692794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-10-21
- Public Version
- 1
- Public Version Date
- 2024-10-29
- Public Version Status
- New
- Public Device Record Key
- 353e04ca-b93e-400b-9c4a-2ea93acd3401
Device Description
Antiviral Earloop Mask, ASTM Level 3
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| OUK | Surgical Mask With Antimicrobial/Antiviral Agent | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66197 | Surgical/medical face mask, 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 includes an antimicrobial/antiviral agent to prevent/inhibit the proliferation of microbes under specified conditions 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 80852212003715 | GS1 | ||||
| Primary | 00852212003719 | GS1 | ||||
| Package | 20852212003713 | GS1 | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 8174272700
- [email protected]