Duns Number:555536276
Device Description: Non-fiberglass, non-irritation, non-carcinogen (formaldehyde)Waterproof, airy, non-irritat Non-fiberglass, non-irritation, non-carcinogen (formaldehyde)Waterproof, airy, non-irritating fabricsEasily adjusted nose clip helps fixed and best fit to faceReliable and elastic earloops for comfortable use.
Catalog Number
-
Brand Name
AMERICANA DISPOSABLE FACE MASK
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
QKR
Product Code Name
Face Mask (Except N95 Respirator) For General Public/Healthcare Personnel Per Iie Guidance
Public Device Record Key
53fce67a-8a4c-4b5e-8f8d-3dd9be02b935
Public Version Date
September 24, 2020
Public Version Number
1
DI Record Publish Date
September 16, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-