Duns Number:025460908
Device Description: MASK,FACE,SURGICAL,FOG FREE,TIES,BLUE,LF
Catalog Number
NON27408
Brand Name
Medline
Version/Model Number
NON27408
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
K991559,K991559,K991559
Product Code
FXX
Product Code Name
Mask, surgical
Public Device Record Key
14b396b2-6657-4a5d-8d8a-30399df9b32a
Public Version Date
February 03, 2021
Public Version Number
1
DI Record Publish Date
January 26, 2021
Package DI Number
30080196752953
Quantity per Package
50
Contains DI Package
10080196752959
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |