FDA.reportPublic FDA data

FLUME catheter

Primary DI
15060894850039
Brand
FLUME catheter
Company
THE FLUME CATHETER COMPANY LIMITED
Model
FLUME catheter Kit 14Fr
Catalog number
1004
Device description
FLUME catheter & Syringe Kit 375mm 14Fr
Published
2024-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZLCatheter, Retention Type, Balloon

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060894850039PackageGS110In Commercial Distribution
25060894850036PackageGS15In Commercial Distribution
05060894850032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506089485003915060894850039
2506089485003625060894850036
05060894850032050608948500325060894850032

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage balloon catheter, non-antimicrobialA flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (833) 940-5050sales@flumecatheter.com

Regulatory Flags#

DUNS number
221621138
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060894850032FLUME catheterFLUME catheter Kit 14Fr10042024-11-14
05060894850049FLUME catheterFLUME catheter Kit 16Fr10062024-11-14
05060894850018FLUME catheter14Fr10032024-11-14
15060894850046FLUME catheterFLUME catheter Kit 16Fr10062024-11-14
05060894850056FLUME catheterFLUME catheter 16Fr10052024-11-14

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