Duns Number:025460908
Device Description: MASK,FACE,MAX FLUID PROTECT,TIES
Catalog Number
NON27712
Brand Name
Medline
Version/Model Number
NON27712
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
Product Code
FXX
Product Code Name
Mask, surgical
Public Device Record Key
c59e0244-37b4-4c1b-9097-94e67ddf6390
Public Version Date
October 19, 2020
Public Version Number
1
DI Record Publish Date
October 09, 2020
Package DI Number
40080196754404
Quantity per Package
6
Contains DI Package
10080196754403
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 | 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 |