Accuryn UO/T Catheter, 16F Kit - The Accuryn Monitoring System is intended for use - POTRERO MEDICAL, INC.

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).

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More Product Details

Catalog Number

FGS-06-UOT.16FS

Brand Name

Accuryn UO/T Catheter, 16F Kit

Version/Model Number

FGS-06-UOT.16FS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Device Record Status

Public Device Record Key

3877332d-a7dc-41c0-8bda-ebcfaff45421

Public Version Date

July 28, 2020

Public Version Number

1

DI Record Publish Date

July 20, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POTRERO MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16