Duns Number:008124539
Device Description: Youth Face Mask, Blue, 5.7" x 3.75" (14.5cm x 9.5cm)
Catalog Number
-
Brand Name
Youth Face Mask
Version/Model Number
2207-YTBL
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)
-
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
1f50d1ba-2753-4c75-9fb9-5f837d238052
Public Version Date
March 02, 2021
Public Version Number
1
DI Record Publish Date
February 22, 2021
Package DI Number
00840117305267
Quantity per Package
12
Contains DI Package
00840117305250
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |