Duns Number:687103537
Device Description: Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, White.The Fluid Res Fluid Resistant Procedure Mask- Flat Pleated, Ear Loops, ASTM Level 3, White.The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.
Catalog Number
-
Brand Name
LHM
Version/Model Number
LHM-E1304
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)
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
e1d7aaeb-7a65-44ef-a210-1f92c680e760
Public Version Date
April 20, 2021
Public Version Number
1
DI Record Publish Date
April 12, 2021
Package DI Number
14897112130045
Quantity per Package
10
Contains DI Package
04897112130048
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case