Identity
- Trade Name
- AMERICANA DISPOSABLE FACE MASK FDA UDI
- Generic Name
- Public face mask, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08936081250237 FDA UDI
- FDA Product Code
- QKR FDA UDI
- GMDN Term
- Public face mask, single-use FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Public face mask, single-use
Americana Disposable Face Mask by Wakamono Corporation — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Public face mask, single-use.
- JMU — JMU DENTAL, INC · Class II
- Child Face Masks — Dynarex Corp. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- JMU — JMU DENTAL, INC · Class II
- ZhengKang — Guangzhou Zhengkang Medical Equipment Co., Ltd · Class II
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · N
- Halyard — O&M HALYARD, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wakamono Corporation
Sources (1)
- FDA UDI 53fce67a-8a4c-4b5e-8f8d-3dd9be02b935 33 fields · synced Jun 8, 2026