Accuryn Temperature Cable Adapter - A reusable short cable adapter that adapts Foleys - POTRERO MEDICAL, INC.

Duns Number:079428290

Device Description: A reusable short cable adapter that adapts Foleys with 3.5mm round connectors to the Reusa A reusable short cable adapter that adapts Foleys with 3.5mm round connectors to the Reusable Accuryn Temperature Cable. The Accuryn Temperature Cable Adapter is an accessory of the Accuryn Monitoring System.

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More Product Details

Catalog Number

FGN-06-102306

Brand Name

Accuryn Temperature Cable Adapter

Version/Model Number

FGN-06-102306

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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

EXY

Product Code Name

Uroflowmeter

Device Record Status

Public Device Record Key

22960468-026a-4504-a401-f4ad7a34fbc0

Public Version Date

October 27, 2022

Public Version Number

1

DI Record Publish Date

October 19, 2022

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