FDA.reportPublic FDA data

TEMPERATURE SENSING FOLEY BALLOON CATHETER

Primary DI
08806369403726
Brand
TEMPERATURE SENSING FOLEY BALLOON CATHETER
Company
Sewoon Medical Co., Ltd.
Model
2105-010
Device description
Temperature Sensing/Blue 3cc 10fr
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZLCatheter, Retention Type, Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0222870003T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS3t Medical Systems, LLC2002-09-23EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806369403726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806369403726088063694037268806369403726

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687784405
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806369400220BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200M2+(3.2)2023-07-27
08806369400244BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200L2+(4.8)2023-07-27
08806369427333BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100M(3.2)S2023-07-27
08806369427371BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200M(3.2)S2023-07-27
08806369427418BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200L(4.8)S2023-07-27
08806369427456BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200L+(4.8)S2023-07-27
08806369427494BAROVAC® Evacuator Closed Wound Drainage System(SS)PS400L(4.8)S2023-07-27
08806369427616BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400M(3.2)N2732023-07-27
08806369427654BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400L(4.8)N2732023-07-27
08806369427692BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400S(2.4)2023-07-27
08806369427739BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400M(3.2)S2023-07-27
08806369427777BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400L(4.8)S2023-07-27
08806369452007BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100M(3.2)2023-07-27
08806369452021BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100M+(3.2)2023-07-27
08806369452045BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100L(4.8)2023-07-27
08806369452069BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100L+(4.8)2023-07-27
08806369452083BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100LD(4.8)2023-07-27
08806369452106BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100JP(4.8)2023-07-27
08806369452120BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100M2(3.2)2023-07-27
08806369452526BAROVAC® Evacuator Closed Wound Drainage System(SS)SS150M+(3.2)2023-07-27

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
10192253067651DoverCardinal Health 200, LLCEZL2025-04-14
10192253067668DoverCardinal Health 200, LLCEZL2025-04-14
10192253067675DoverCardinal Health 200, LLCEZL2025-04-14
10192253067682DoverCardinal Health 200, LLCEZL2025-04-14
10192253031423DoverCardinal Health 200, LLCEZL2025-01-15
10192253031409DoverCardinal Health 200, LLCEZL2025-01-14
10192253031416DoverCardinal Health 200, LLCEZL2025-01-14
10192253038897DoverCardinal Health 200, LLCEZL2025-01-14
10192253031140DoverCardinal Health 200, LLCEZL2024-12-20
10192253031164DoverCardinal Health 200, LLCEZL2024-12-20
10192253066203DoverCardinal Health 200, LLCEZL2024-09-04
10192253066210DoverCardinal Health 200, LLCEZL2024-09-04
10192253066227DoverCardinal Health 200, LLCEZL2024-09-04
10192253066234DoverCardinal Health 200, LLCEZL2024-09-04
10192253066241DoverCardinal Health 200, LLCEZL2024-09-04
10192253066258DoverCardinal Health 200, LLCEZL2024-09-04
10192253066265DoverCardinal Health 200, LLCEZL2024-09-04
10192253066272DoverCardinal Health 200, LLCEZL2024-09-04
10192253066289DoverCardinal Health 200, LLCEZL2024-09-04
10192253066296DoverCardinal Health 200, LLCEZL2024-09-04
10192253066302DoverCardinal Health 200, LLCEZL2024-09-04
10192253066319DoverCardinal Health 200, LLCEZL2024-09-04
10192253066326DoverCardinal Health 200, LLCEZL2024-09-04
10192253066333DoverCardinal Health 200, LLCEZL2024-09-04
10192253066340DoverCardinal Health 200, LLCEZL2024-09-04