Duns Number:022542271
Device Description: 00092237603116
Catalog Number
-
Brand Name
Roscoe Medical
Version/Model Number
50040
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 07, 2019
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
19b40bb4-97c6-47fc-8c1b-5b8109216ae6
Public Version Date
May 08, 2019
Public Version Number
3
DI Record Publish Date
October 05, 2016
Package DI Number
60092237603118
Quantity per Package
6
Contains DI Package
00092237603116
Package Discontinue Date
May 07, 2019
Package Status
Not 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |