Duns Number:025460908
Device Description: MASK,FACE,EARLOOPS,PINK RIBBON
Catalog Number
NONRIBBONEL
Brand Name
Medline
Version/Model Number
NONRIBBONEL
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
55cd973e-c4c9-4c41-8cc3-6bb7d26a8128
Public Version Date
February 03, 2021
Public Version Number
1
DI Record Publish Date
January 26, 2021
Package DI Number
40080196417880
Quantity per Package
300
Contains DI Package
30080196417883
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |