Duns Number:791014871
Device Description: DK N95 Mask Cone w/ 1way valve
Catalog Number
1572
Brand Name
Dukal
Version/Model Number
1572
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 22, 2022
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
K070692,K070692,K070692
Product Code
MSH
Product Code Name
Respirator, surgical
Public Device Record Key
dc2ce5c4-076f-4062-8f8e-c139a3ca19dc
Public Version Date
May 23, 2022
Public Version Number
9
DI Record Publish Date
September 24, 2016
Package DI Number
20665973005779
Quantity per Package
20
Contains DI Package
10665973005772
Package Discontinue Date
March 22, 2022
Package Status
Not 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |
| U | Unclassified | 1 |