Duns Number:867673159
Device Description: SleepMasks Product Description: NasalFit Deluxe EZ CPAP Mask, LG, 1/ea
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
100NDEL
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
fb400214-1681-4b97-b18d-f3622f96731a
Public Version Date
July 16, 2019
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
50822383543746
Quantity per Package
50
Contains DI Package
00822383543741
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 |