FDA UDI
In Commercial Distribution
🇺🇸 United States
AMERICANA DISPOSABLE FACE MASK
DI: 08936081250237
·
Model: 1
·
WAKAMONO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- AMERICANA DISPOSABLE FACE MASK
- Primary DI
- 08936081250237
- Version / Model
- 1
- Company Name
- WAKAMONO CORPORATION
- Labeler DUNS
- 555536276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-09-16
- Public Version
- 1
- Public Version Date
- 2020-09-24
- Public Version Status
- New
- Public Device Record Key
- 53fce67a-8a4c-4b5e-8f8d-3dd9be02b935
Device Description
Non-fiberglass, non-irritation, non-carcinogen (formaldehyde) Waterproof, airy, non-irritating fabrics Easily adjusted nose clip helps fixed and best fit to face Reliable and elastic earloops for comfortable use.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QKR | Face Mask (Except N95 Respirator) For General Public/Healthcare Personnel Per Iie Guidance | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64821 | Public face mask, single-use | A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; 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). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08936081250237 | GS1 | ||||
| Unit of Use | 89360812502374 | GS1 |