Duns Number:961027315
Device Description: Compressor Nebulizer
Catalog Number
ZRCN01
Brand Name
CARDINAL HEALTH
Version/Model Number
ZRCN01
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)
-
Over the Counter (OTC)
Yes
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
eea6e625-3acd-4574-900e-8937a7d50085
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 14, 2016
Package DI Number
50885380116191
Quantity per Package
6
Contains DI Package
00885380116196
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |