Duns Number:827221698
Device Description: Roscoe Rite-Neb 4 Nebulizer Compressor with Disposable Neb Kit
Catalog Number
-
Brand Name
Roscoe Medical
Version/Model Number
NEB-RITE4
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
841ce44b-1e88-4b7c-a054-c80650d00a97
Public Version Date
May 14, 2018
Public Version Number
1
DI Record Publish Date
April 12, 2018
Package DI Number
30092237619804
Quantity per Package
6
Contains DI Package
00092237619803
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| 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 |