FDA.report

FLUME catheter

Primary DI
05060894850018
Brand
FLUME catheter
Company
THE FLUME CATHETER COMPANY LIMITED
Model
14Fr
Catalog number
1003
Device description
FLUME catheter 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

Related Records

Contact Domains

Product Codes

CodeName
EZLCatheter, Retention Type, Balloon

Product Code Classifications

CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060894850018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060894850018050608948500185060894850018

GMDN Terms

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

Contacts

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
false
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 DIBrandModelCatalogPublished
15060894850039FLUME catheterFLUME catheter Kit 14Fr10042024-11-14
15060894850046FLUME catheterFLUME catheter Kit 16Fr10062024-11-14
05060894850056FLUME catheterFLUME catheter 16Fr10052024-11-14

Other Devices Sharing Product Codes

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50192253067659DoverCardinal Health 200, LLCEZL2025-04-14
20192253067665DoverCardinal Health 200, LLCEZL2025-04-14
50192253067673DoverCardinal Health 200, LLCEZL2025-04-14
20192253067689DoverCardinal Health 200, LLCEZL2025-04-14
20884522000014Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000024Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000031Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000048Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000055Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000062Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
00850029182016Egress Safety CatheterInnoCare Urologics, LLCEZL2025-03-19
27290110066516Covidien AGDEGANIA SILICONE LTDEZL2025-03-04
27290110066479Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066486Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066493Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066509Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066523Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
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16944932785653All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785684All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785714All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785752All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785790All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785820All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785844All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785875All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785882All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785912All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05