FDA.reportPublic FDA data

Accuryn Monitor Short Floor Stand

Primary DI
00850019755213
Brand
Accuryn Monitor Short Floor Stand
Company
POTRERO MEDICAL, INC.
Model
FGN-06-102427
Catalog number
FGN-06-102427
Device description
The Accuryn Monitor Short Floor Stand is used to hold the Accuryn Monitor on the floor near the patient’s bed during stationary use. The Accuryn Monitor Short Floor Stand is an accessory of the Accuryn Monitoring System.
Published
2022-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXYUroflowmeter
EZLCatheter, Retention Type, Balloon
PHUIntra-Abdominal Pressure Monitoring Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXYUroflowmeterGastroenterology, Urology2
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2
PHUIntra-Abdominal Pressure Monitoring DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153655000Accuryn Monitoring SystemPotrero Medical, Inc.2016-04-15EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019755213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019755213008500197552138500197552130850019755213

GMDN Terms#

Term, Definition table
TermDefinition
Urine monitoring systemAn assembly of devices intended to automatically and continuously monitor and display a patient's urine output (urine flow/volume). The system typically consists of a battery-powered, portable monitor with controls, digital display, alarms, and memory; an electronic (e.g., optical) urine output sensor; and a disposable urine collection container. The system is typically used in situations where fluid and renal management are critical to patient treatment and care [e.g., during diuresis monitoring in the intensive care unit (ICU)].

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079428290
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850019755145Accuryn SmartFoley UO Temp Tray System 16FrFGS-06-UOT.16FSTFGS-06-UOT.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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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