Duns Number:079428290
Device Description: The Accuryn Monitoring System is intended for use in the drainage and/or collection of uri The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS).
Catalog Number
FGS-06-IAP.16FS
Brand Name
Accuryn UO/T-IAP Catheter, 16F Kit
Version/Model Number
FGS-06-IAP.16FS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
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
K153655
Product Code
EZL
Product Code Name
Catheter, Retention Type, Balloon
Public Device Record Key
81d1160e-7ce7-43bd-bcd1-2d66a6a2b0e2
Public Version Date
July 28, 2020
Public Version Number
1
DI Record Publish Date
July 20, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |