Duns Number:413008652
Device Description: e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters are int e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
Catalog Number
37041005
Brand Name
e∙Sense
Version/Model Number
Bladder, Single Sensor Catheter, Straight tip shape
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
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
FEN
Product Code Name
Device, Cystometric, Hydraulic
Public Device Record Key
0adc00d6-cf81-4f38-942a-95e4dd793c01
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 01, 2016
Package DI Number
38718122028323
Quantity per Package
10
Contains DI Package
08718122028322
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 533 |