Duns Number:117512312
Device Description: A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healt A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; 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) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.
Catalog Number
-
Brand Name
EcoGuard® Surgical Mask
Version/Model Number
EcoGuard B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
329a32a1-43f3-4adb-9c38-1a37738d3c2c
Public Version Date
March 08, 2021
Public Version Number
1
DI Record Publish Date
February 26, 2021
Package DI Number
B927FA00112
Quantity per Package
40
Contains DI Package
B927FA00111
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case