Duns Number:867673159
Device Description: FULLFACE MASK,COM-FIT DLX,SMW/OHDG, 1/EA
Catalog Number
-
Brand Name
Noridian Healthcare
Version/Model Number
100FDS-NH
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZD
Product Code Name
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Public Device Record Key
438c4cfc-5cf8-4a00-8ed2-15bcee022c56
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
10822383525218
Quantity per Package
50
Contains DI Package
00822383525211
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |