AccessGUDID - DEVICE: Accuryn SmartFoley IAP UO Temp Tray System 12Fr (00850019755107)

GUDID

Device Identifier (DI) Information

Brand Name: Accuryn SmartFoley IAP UO Temp Tray System 12Fr
Version or Model: FGS-06-IAP.12FST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FGS-06-IAP.12FST
Company Name: POTRERO MEDICAL, INC.

Primary DI Number: 00850019755107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079428290 *Terms of Use

Device Description: 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 with the Accuryn Sensing Urinary Catheter (SmartFoley) – IAP UO Temp 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). The Accuryn Sensing Urinary Catheter is a single use device intended for short term use (less than 30 days).

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63635	Multi-parameter urinary monitoring system catheter set	A collection of sterile devices intended to be used in a multi-parameter urinary monitoring system to provide continuous urinary drainage with measured collection, and to detect intra-abdominal pressure (via intra-bladder pressure) and core temperature (via intra-bladder temperature). It consists of a specialized urethral catheter with distal sensors/transducers for measurement of pressure and temperature, a urinary collection cassette and collection bag, with connecting tubing. It is typically used in an intensive care setting to manage acute renal failure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZL	Catheter, Retention Type, Balloon
PHU	Intra-Abdominal Pressure Monitoring Device
EXY	Uroflowmeter
OUG	Medical Device Data System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221020	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 5 and 60 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight
Storage Environment Temperature: between 5 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 12 French

Device Record Status

Public Device Record Key: c917a8cd-3457-4c2c-bda5-b1e3c725bac2
Public Version Date: July 20, 2023
Public Version Number: 2
DI Record Publish Date: March 30, 2023