AccessGUDID - DEVICE: Accuryn SmartFoley Tray System Foley Adapter (00850019755176)

GUDID

Device Identifier (DI) Information

Brand Name: Accuryn SmartFoley Tray System Foley Adapter
Version or Model: FGS-06-UOT.SMCS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FGS-06-UOT.SMCS
Company Name: POTRERO MEDICAL, INC.

Primary DI Number: 00850019755176
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 SmartFoley 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?
64572	Multi-parameter urinary monitoring system connection set	A collection of noninvasive devices intended to be used to make connections in a multi-parameter urinary monitoring system during continuous urinary drainage with measured collection, and detection of intra-abdominal pressure (via intra-bladder pressure) and core temperature (via intra-bladder temperature). It typically includes an electrical cable(s), tubing, and urine collection bag, and is intended to connect to a specialized urethral sensor catheter (not included) and the system control unit (not included). 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
EXY	Uroflowmeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 5 and 60 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad8656c3-43cf-4cb9-83e4-386aafabea91
Public Version Date: July 14, 2023
Public Version Number: 2
DI Record Publish Date: September 29, 2021