Duns Number:054318779
Device Description: Mouthpiece for Use with Nebulizer Kit
Catalog Number
C910
Brand Name
Omron Mouthpiece for Nebulizer
Version/Model Number
C910
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
K060811,K060811
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
26b4d087-63b5-4ec3-813b-acc236aeb29d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 17, 2017
Package DI Number
10073796391000
Quantity per Package
150
Contains DI Package
00073796391003
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 |