Duns Number:256880576
Device Description: Medicom Safemask ArchitectPro - Surgical/N95 Respirator - White - Small
Catalog Number
203214
Brand Name
Medicom SafeMask
Version/Model Number
203214
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
fcf8e8b6-a444-4238-8eae-267a64e83f66
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
January 28, 2022
Package DI Number
20686864056908
Quantity per Package
10
Contains DI Package
10686864056901
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |