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 Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use
Primary Device ID08936081250237
NIH Device Record Key53fce67a-8a4c-4b5e-8f8d-3dd9be02b935
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMERICANA DISPOSABLE FACE MASK
Version Model Number1
Company DUNS555536276
Company NameWAKAMONO CORPORATION
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108936081250237 [Primary]
GS189360812502374 [Unit of Use]

FDA Product Code

QKRFace Mask (Except N95 Respirator) For General Public/Healthcare Personnel Per Iie Guidance

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-24
Device Publish Date2020-09-16

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