Duns Number:054318779
Device Description: Omron compressor nebulizer, with nebulizer kit and pediatric mask.
Catalog Number
RE-C800KD
Brand Name
Omron CompAir Compressor Nebulizer
Version/Model Number
RE-C800KD
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
K141140,K141140
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
226829ae-9604-487d-a316-a26cd3ab0de6
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 03, 2020
Package DI Number
10073796800144
Quantity per Package
10
Contains DI Package
00073796800147
Package Discontinue Date
-
Package Status
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |