FDA.reportPublic FDA data

Accuryn SmartFoley UO Temp Tray System 16Fr

Primary DI
00850019755145
Brand
Accuryn SmartFoley UO Temp Tray System 16Fr
Company
POTRERO MEDICAL, INC.
Model
FGS-06-UOT.16FST
Catalog number
FGS-06-UOT.16FST
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).
Published
2021-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXYUroflowmeter
EZLCatheter, Retention Type, Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXYUroflowmeterGastroenterology, Urology2
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850019755142PackageGS110In Commercial Distribution
00850019755145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001975514210850019755142
00850019755145008500197551458500197551450850019755145

GMDN Terms#

Term, Definition table
TermDefinition
Multi-parameter urinary monitoring system catheter setA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Keep Away from Sunlight
Storage Environment Temperature5 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1-833-222-8796cs@potreromed.com

Regulatory Flags#

DUNS number
079428290
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019755213Accuryn Monitor Short Floor StandFGN-06-102427FGN-06-1024272022-10-19
00850019755220Accuryn Monitor Floor StandFGN-06-100195FGN-06-1001952022-10-19
00850019755237Accuryn Monitor Mount with ClampFGN-06-100202FGN-06-1002022022-10-19
00850019755244Accuryn Monitor High MountFGN-06-102112FGN-06-1021122022-10-19
00850019755251Accuryn Monitor High Mount & Floor StandFGN-06-102111FGN-06-1021112022-10-19
00850019755008Accuryn Temperature CableFGN-06-100779FGN-06-1007792022-10-19
00850019755206Accuryn Temperature Cable AdapterFGN-06-102306FGN-06-1023062022-10-19
00850019755107Accuryn SmartFoley IAP UO Temp Tray System 12FrFGS-06-IAP.12FSTFGS-06-IAP.12FST2023-03-30
00850019755015AccuTabFGN-06-101581FGN-06-1015812023-04-13
00850019755121Accuryn SmartFoley IAP UO Temp Tray System 16FrFGS-06-IAP.16FSTFGS-06-IAP.16FST2021-09-29
00850019755152Accuryn SmartFoley Coude UO Temp Tray System 16FrFGS-06-CUOT.16FSTFGS-06-CUOT.16FST2021-10-19
00850019755176Accuryn SmartFoley Tray System Foley AdapterFGS-06-UOT.SMCSFGS-06-UOT.SMCS2021-09-29
00868475000280Accuryn UO/T, Smart Cath KitFGS-06-UOT.SMCSFGS-06-UOT.SMCS2020-07-20
00868475000297Accuryn UO/T Catheter, 16F KitFGS-06-UOT.16FSFGS-06-UOT.16FS2020-07-20
00868475000235Accuryn MonitorFGN-06-2687FGN-06-26872018-01-22
00868475000273Accuryn UO/T-IAP Catheter, 16F KitFGS-06-IAP.16FSFGS-06-IAP.16FS2020-07-20
00850019755114Accuryn SmartFoley IAP UO Temp Tray System 14FrFGS-06-IAP.14FSTFGS-06-IAP.14FST2023-03-30
10850019755104Accuryn SmartFoley IAP UO Temp Tray System 12FrFGS-06-IAP.12FSTFGS-06-IAP.12FST2023-03-30
10850019755111Accuryn SmartFoley IAP UO Temp Tray System 14FrFGS-06-IAP.14FSTFGS-06-IAP.14FST2023-03-30
00850019755169Accuryn SmartFoley 3-Way UO Tray System 18FrFGS-06-3UO.18FSFGS-06-3UO.18FS2021-10-19

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Primary DI, Brand, Company table
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