Duns Number:557034526
Device Description: Prevent dust and pollutants from the environmentStandard quality of dust filterSoft elasti Prevent dust and pollutants from the environmentStandard quality of dust filterSoft elastic earloops for comfortable use.
Catalog Number
-
Brand Name
MONOPOWER 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
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
1b738b0d-849c-46d4-b46a-9264cf9e542b
Public Version Date
October 22, 2020
Public Version Number
1
DI Record Publish Date
October 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-