FDA.reportPublic FDA data

Level 1

Primary DI
15019517061826
Brand
Level 1
Company
ICU MEDICAL, INC.
Model
Urine Meter Foley Tray with Temperature
Published
2016-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K933400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933400000KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSORKendall Healthcare Products Co. Div.Of Tyco Health1993-11-15KOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15019517061826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951706182615019517061826

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kitA collection of sterile devices that includes an indwelling urethral catheter (commonly known as a Foley catheter), gloves, lubricating gel, and other related accessories intended for the drainage of urine from the bladder. The catheter has an inflatable balloon at the distal tip for retention in the urinary bladder after its insertion through the urethra, where it usually functions as an indwelling therapeutic device for urinary incontinence or as a means to void for non-ambulatory patients. The catheter will be applied by trained staff and may or may not be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709203263BivonaFT26IN40NGE030N2026-09-04
10887709203270BivonaXT26IS70NSC031N2026-09-04
10887709203287BivonaFT26IN40NSF032N2026-09-04
10887709203294BivonaFT26IN50NSF034N2026-09-04
10887709203300BivonaFT26IN55NSF033N2026-09-04
10887709203324BivonaFT26IN30NSE036N2026-09-04
10887709201641BivonaZT26DN50NSZ214S2026-08-27
10887709202174BivonaST26HN80ZSZ137N2026-08-27
10887709202426BivonaFT26HN45NSF207N2026-08-27
10887709202433BivonaFU26HN40NGF213N2026-08-27
10887709202440BivonaFT26HN45NGA211N2026-08-27
10887709202464BivonaFT26HN30NGE215N2026-08-27
10887709202471BivonaFT26HN35NGE214N2026-08-27
10887709202259BivonaFU26HN35NGA187N2026-08-26
10887709202266BivonaFT26HN35NGE188N2026-08-26
10887709202273BivonaFU26HN40NGA186N2026-08-26
10887709202280BivonaFT26HN35NGF189N2026-08-26
10887709202297BivonaFU26HN40NGF190N2026-08-26
10887709202303BivonaFT26HN40NSE076N2026-08-26
10887709202310BivonaFU26HN25NGE191N2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704926944RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704926951RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704926968RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704933843RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704925732RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925749RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925763RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925770RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925787RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925947RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
10192253031782DoverCardinal Health 200, LLCKOD2026-06-18
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
10192253024272DoverCardinal Health 200, LLCKOD2026-03-20
10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253067651DoverCardinal Health 200, LLCKOD2025-04-14
10192253067668DoverCardinal Health 200, LLCKOD2025-04-14
10192253067675DoverCardinal Health 200, LLCKOD2025-04-14
10192253030365DoverCardinal Health 200, LLCKOD2025-04-07
10192253066289DoverCardinal Health 200, LLCKOD2024-09-04
10192253066296DoverCardinal Health 200, LLCKOD2024-09-04
10192253066302DoverCardinal Health 200, LLCKOD2024-09-04
10192253066319DoverCardinal Health 200, LLCKOD2024-09-04
10192253066326DoverCardinal Health 200, LLCKOD2024-09-04
10192253066333DoverCardinal Health 200, LLCKOD2024-09-04
10192253066340DoverCardinal Health 200, LLCKOD2024-09-04
10192253066357DoverCardinal Health 200, LLCKOD2024-09-04
10192253066364DoverCardinal Health 200, LLCKOD2024-09-04
10192253066371DoverCardinal Health 200, LLCKOD2024-09-04
10192253066388DoverCardinal Health 200, LLCKOD2024-09-04