Duns Number:654591569
Device Description: BGEcare Disposable Face Mask, Blue, Narrow Spandex Ear Loops, 50 pieces/box, 40 boxes/cart BGEcare Disposable Face Mask, Blue, Narrow Spandex Ear Loops, 50 pieces/box, 40 boxes/carton box
Catalog Number
-
Brand Name
BGEcare Disposable Face Mask
Version/Model Number
MM17185040L1
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"
-
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
52e150e5-cecd-4c15-8b8d-3ed4d445d23a
Public Version Date
March 12, 2021
Public Version Number
1
DI Record Publish Date
March 04, 2021
Package DI Number
06959385795947
Quantity per Package
40
Contains DI Package
06959385795930
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |