Duns Number:827221698
Device Description: Bunny Nebulizer Compressor System with Reusable and Disposable Neb Kits and Carry Bag
Catalog Number
-
Brand Name
Roscoe Medical
Version/Model Number
BUNNY-TRUWB-PB
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
BTI
Product Code Name
Compressor, Air, Portable
Public Device Record Key
45d548e8-0ac4-4811-b0ca-d294de669b63
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
December 19, 2018
Package DI Number
30092237620725
Quantity per Package
6
Contains DI Package
00092237620724
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 |