FDA.reportPublic FDA data

Medline

Primary DI
10888277688483
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
UROACCRN200
Catalog number
UROACCRN200
Device description
DBD-ACCURYN MONITORING DEVICE
Published
2021-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXYUROFLOWMETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXYUroflowmeterGastroenterology, Urology2

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
10888277688483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827768848310888277688483

GMDN Terms#

Term, Definition table
TermDefinition
Temperature-monitoring indwelling urethral drainage catheterA sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring of core body temperature through its integral temperature sensor, typically during or after surgery or in the presence of obstruction or paralysis. It may have a bent tip (coude) for negotiation of the prostatic curve and is typically made of silicone. It is inserted by trained staff and commonly known as a Foley catheter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature-18 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00086000980061GleanBright Uro, IncEXY2025-09-23
00860009800601GleanBright Uro, IncEXY2025-09-23
00860009800632GleanBright Uro, IncEXY2025-09-23
00860009800649GleanBright Uro, IncEXY2025-09-23
00860009800656GleanBright Uro, IncEXY2025-09-23
07290019239017FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
07290019239024FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
07290019239031FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
07290019239208FIZE kUO Disposable Pediatric KitFIZE RESEARCH LTDEXY2025-04-29
07290019239215FIZE kUO Disposable Kit FIZE RESEARCH LTDEXY2025-04-29
07290019239284FIZE kUO Disposable Pediatrics kit, UrinemeterFIZE RESEARCH LTDEXY2025-04-29
07290019239291FIZE kUO Disposable Adult kit, UrinemeterFIZE RESEARCH LTDEXY2025-04-29
17290019239014FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
17290019239021FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
17290019239038FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
17290019239205FIZE kUO Disposable Pediatric KitFIZE RESEARCH LTDEXY2025-04-29
17290019239212FIZE kUO Disposable Kit FIZE RESEARCH LTDEXY2025-04-29
17290019239281FIZE kUO Disposable Pediatrics kit, UrinemeterFIZE RESEARCH LTDEXY2025-04-29
17290019239298FIZE kUO Disposable Adult kit, UrinemeterFIZE RESEARCH LTDEXY2025-04-29
07290019239222FIZE kUO Disposable Pediatrics kit, UrinometerFIZE RESEARCH LTDEXY2025-04-28
07290019239239FIZE kUO Disposable kit PediatricsFIZE RESEARCH LTDEXY2025-04-28
07290019239246FIZE kUO Disposable KitFIZE RESEARCH LTDEXY2025-04-28
17290019239229FIZE kUO Disposable Pediatrics kit, UrinometerFIZE RESEARCH LTDEXY2025-04-28
17290019239236FIZE kUO Disposable kit PediatricsFIZE RESEARCH LTDEXY2025-04-28
17290019239243FIZE kUO Disposable KitFIZE RESEARCH LTDEXY2025-04-28
07290019239277FIZE kUO ConsoleFIZE RESEARCH LTDEXY2025-04-27
04650075336922RivusNEUROSOFT, OOOEXY2024-12-20
00860003478714TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESEXY2024-07-06
00860003478721TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESEXY2024-07-06
00860003478738TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESEXY2024-07-06