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.16FST
Brand Name
Accuryn SmartFoley IAP UO Temp Tray System 16Fr
Version/Model Number
FGS-06-IAP.16FST
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"
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
K153655,K153655
Product Code
EZL
Product Code Name
Catheter, Retention Type, Balloon
Public Device Record Key
7b313eb2-9a09-4343-8761-315f586464a5
Public Version Date
October 07, 2021
Public Version Number
1
DI Record Publish Date
September 29, 2021
Package DI Number
10850019755128
Quantity per Package
10
Contains DI Package
00850019755121
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |