Duns Number:082522269
Device Description: DreamEasy Nasal Mask
Catalog Number
-
Brand Name
Carex Health Brands
Version/Model Number
FGC10200 0000
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
af6b8d72-8be7-4d3e-8438-83b168fc150b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 07, 2016
Package DI Number
30023601071027
Quantity per Package
6
Contains DI Package
00023601071026
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 34 |