FDA.reportPublic FDA data

AccuTab

Primary DI
00850019755015
Brand
AccuTab
Company
POTRERO MEDICAL, INC.
Model
FGN-06-101581
Catalog number
FGN-06-101581
Device description
AccuTab is a tablet with associated software (AccuData) that connects to the Accuryn Monitor. The tablet is an extension of the Accuryn Monitor and only displays the data that already exists on the Accuryn Monitor. AccuTab with AccuData is solely intended to transfer, store, convert forms, and display medical device data from the Accuryn Monitor.
Published
2023-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZLCatheter, Retention Type, Balloon
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2
OUGMedical Device Data SystemGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221020000Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 FPotrero Medical, Inc.2023-01-13EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019755015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019755015008500197550158500197550150850019755015

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079428290
Device count
1
Serial number
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
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
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
Primary DIBrandCompanyProduct codePublished
08886483507470Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
10192253068221DoverCardinal Health 200, LLCEZL2026-01-15
10192253068238DoverCardinal Health 200, LLCEZL2026-01-15
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10192253067651DoverCardinal Health 200, LLCEZL2025-04-14
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