Duns Number:006959555
Device Description: MEIJER CONE STYLE FACE MASK 10 CT
Catalog Number
2609428
Brand Name
Meijer
Version/Model Number
MJ381R
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
MSH
Product Code Name
Respirator,Surgical
Public Device Record Key
9651a7bd-b214-4497-8074-a7ed766b29d0
Public Version Date
May 06, 2020
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
40708820342208
Quantity per Package
24
Contains DI Package
00708820342200
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |