AMERICANA DISPOSABLE FACE MASK

GUDID 08936081250237

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.

WAKAMONO CORPORATION

Public face mask, single-use

• Primary Device ID: 08936081250237
• NIH Device Record Key: 53fce67a-8a4c-4b5e-8f8d-3dd9be02b935
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMERICANA DISPOSABLE FACE MASK
• Version Model Number: 1
• Company DUNS: 555536276
• Company Name: WAKAMONO CORPORATION
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08936081250237 [Primary]
GS1	89360812502374 [Unit of Use]

FDA Product Code

• QKR: Face Mask (Except N95 Respirator) For General Public/Healthcare Personnel Per Iie Guidance

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-24
• Device Publish Date: 2020-09-16