Duns Number:002348191
Device Description: RUSCH EZ-Blocker(TM) Kit
Catalog Number
MG-02770-002
Brand Name
RUSCH
Version/Model Number
IPN913391
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121462,K121462
Product Code
CBI
Product Code Name
TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
Public Device Record Key
8eaa917f-3147-4228-93f2-4d6832a327f3
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
March 01, 2019
Package DI Number
20801902142379
Quantity per Package
5
Contains DI Package
10801902142372
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |