FDA UDI
In Commercial Distribution
🇺🇸 United States
YADU
DI: 06946015152133
·
Model: Ear loops (Model E)
·
HENAN YADU INDUSTRY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- YADU
- Primary DI
- 06946015152133
- Version / Model
- Ear loops (Model E)
- Company Name
- HENAN YADU INDUSTRY CO., LTD.
- Labeler DUNS
- 421327507
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2026-04-20
- Public Version
- 1
- Public Version Date
- 2026-04-28
- Public Version Status
- New
- Public Device Record Key
- 89ddb793-7275-43d9-96b8-3c5c18523f56
Device Description
YADU Surgical Masks (Model E (ear loops, sterile/non-sterile), Model T (tie on straps, sterile/non-sterile) are intendedto be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, andparticulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood andbody fluids. This is a single use, disposable device, provided sterile and non sterile.
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 06946015152133 | GS1 | ||||
| Unit of Use | 16946015152130 | GS1 | ||||
| Direct Marking | 16946015152130 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212330 | 000 |