Duns Number:006961700
Device Description: Face Masks,Non medical, 50ct, UP&UP
Catalog Number
-
Brand Name
UP&UP
Version/Model Number
245-07-0430
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
KHA
Product Code Name
Mask, Scavenging
Public Device Record Key
e7b39124-4cef-45d7-a824-87610dedb1bd
Public Version Date
December 29, 2020
Public Version Number
1
DI Record Publish Date
December 21, 2020
Package DI Number
10855303008782
Quantity per Package
40
Contains DI Package
00855303008785
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |
| U | Unclassified | 12 |