FDA.reportPublic FDA data

Accuryn Monitor High Mount

Primary DI
00850019755244
Brand
Accuryn Monitor High Mount
Company
POTRERO MEDICAL, INC.
Model
FGN-06-102112
Catalog number
FGN-06-102112
Device description
The Accuryn Monitor High Mount is used to hold Accuryn Monitor near the patient’s bed during stationary use or transport. The Monitor High Mount can also be placed on top of the Floor Stand to raise the drainage bag up to drain the bag more easily. This monitor mount consists of one molded piece.
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
00850019755244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019755244008500197552448500197552440850019755244

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
Lot or batch
true
Manufacturing date on label
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
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

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