Duns Number:827221698
Device Description: ROSCOE NEBGO ULTRASONIC HANDHELD NEBULIZER WITH CARRY TOTE
Catalog Number
-
Brand Name
Roscoe Medical
Version/Model Number
NEB-GO
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
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
7fc31bf1-66cc-4d6c-b8b9-fc7992c7f636
Public Version Date
October 09, 2019
Public Version Number
1
DI Record Publish Date
October 01, 2019
Package DI Number
30092237621739
Quantity per Package
10
Contains DI Package
00092237621738
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 | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |
| U | Unclassified | 2 |