Duns Number:080361159
Device Description: MASK, LVL 2 FACE, BLUE W/HEARTS, EARLOOPS, 3-PLY, ASTM 1862, 50EA/BX, 40BX/CS (2000EA/CS)
Catalog Number
-
Brand Name
ASP MEDICAL
Version/Model Number
FMT605HEART
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)
Yes
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
ca6e032f-ba24-4c40-9b25-535a0696be96
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 09, 2022
Package DI Number
10840216110929
Quantity per Package
50
Contains DI Package
00840216110922
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER PACK
| 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 |