Duns Number:080361159
Device Description: MASK, LV2 FACE, W/VISOR, EARLOOPS, BLUE, ANTI-FOG FOAM
Catalog Number
-
Brand Name
ASP MEDICAL
Version/Model Number
FMT640V
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182515,K182515,K182515
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
7e3736a9-15c3-46c2-8c5c-7478f1873fa4
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 21, 2020
Package DI Number
10840216109015
Quantity per Package
25
Contains DI Package
00840216109018
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |