FDA.reportPublic FDA data

Accuryn Temperature Cable Adapter

Primary DI
00850019755206
Brand
Accuryn Temperature Cable Adapter
Company
POTRERO MEDICAL, INC.
Model
FGN-06-102306
Catalog number
FGN-06-102306
Device description
A reusable short cable adapter that adapts Foleys with 3.5mm round connectors to the Reusable Accuryn Temperature Cable. The Accuryn Temperature Cable Adapter 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
PHUIntra-Abdominal Pressure Monitoring Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXYUroflowmeterGastroenterology, 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
00850019755206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019755206008500197552068500197552060850019755206

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
No natural rubber latex
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
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
Primary DIBrandCompanyProduct codePublished
00086000980061GleanBright Uro, IncEXY2025-09-23
00860009800601GleanBright Uro, IncEXY2025-09-23
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00860009800656GleanBright Uro, IncEXY2025-09-23
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17290019239243FIZE kUO Disposable KitFIZE RESEARCH LTDEXY2025-04-28
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