Duns Number:002348191
Device Description: SoftSimplastic 3 Way Foley Couvelaire Tip Catheter
Catalog Number
664130-000200
Brand Name
RUSCH
Version/Model Number
IPN052929
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)
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
-
Product Code
EZL
Product Code Name
CATHETER, RETENTION TYPE, BALLOON
Public Device Record Key
20e405f0-5a2b-4cde-8623-5d772a329ac3
Public Version Date
November 23, 2020
Public Version Number
1
DI Record Publish Date
November 13, 2020
Package DI Number
44026704302633
Quantity per Package
12
Contains DI Package
24026704302639
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 | 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 |