AccessGUDID - DEVICE: Accuryn UO/T, Smart Cath Kit (00868475000280)

GUDID

Device Identifier (DI) Information

Brand Name: Accuryn UO/T, Smart Cath Kit
Version or Model: FGS-06-UOT.SMCS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FGS-06-UOT.SMCS
Company Name: POTRERO MEDICAL, INC.

Primary DI Number: 00868475000280
Issuing Agency: GS1
Commercial Distribution End Date: May 19, 2023
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 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).

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":	No
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c54a89d9-9503-4d07-84a3-c0ee0bb3846f
Public Version Date: July 14, 2023
Public Version Number: 2
DI Record Publish Date: July 20, 2020