Duns Number:025460908
Device Description: MASK,FACE,CHAMBER,FLUID RESIST,TIES
Catalog Number
NON27382FR
Brand Name
Medline
Version/Model Number
NON27382FR
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
2a6b3a50-4011-413a-9a2a-cb2fdf9b67c5
Public Version Date
May 06, 2020
Public Version Number
3
DI Record Publish Date
October 14, 2016
Package DI Number
30080196415506
Quantity per Package
50
Contains DI Package
10080196415502
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 |