Duns Number:002348191
Device Description: St. Bartholomew Catheter with 250cc Balloon
Catalog Number
264030
Brand Name
RUSCH
Version/Model Number
IPN050004
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 21, 2018
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
K841036,K841036,K841036
Product Code
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
b40301db-e3d9-44b8-8162-f65b5e104fca
Public Version Date
December 10, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
44026704302152
Quantity per Package
10
Contains DI Package
24026704302158
Package Discontinue Date
September 21, 2018
Package Status
Not 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 | 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 |