Duns Number:080728314
Device Description: Small DreamWear Under the Nose Small Frame with Headgear Korea
Catalog Number
1116685KR
Brand Name
DreamWear
Version/Model Number
00
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
-
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
K140980
Product Code
BZD
Product Code Name
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Public Device Record Key
03633071-4b27-414d-822a-8082fafcc506
Public Version Date
June 23, 2020
Public Version Number
1
DI Record Publish Date
June 15, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 151 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3279 |