CATHETER, FOLEY STRAIGHT TIP SILICONE COATED LATEX 16" 16FR 5-15CC


Product Overview

CATHETER, FOLEY STRAIGHT TIP SILICONE COATED LATEX 16" 16FR 5
McKesson - 16-SLFOL516


Device Description

A 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.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: EZL

Device Name: Catheter, Retention Type, Balloon

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.5130

Third Party Flag: Y

Medical Specialty: GU


Device Identifiers

Device Id: 40612479245875

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20612479245864

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case


Device Id: 20612479245864

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10612479245850

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box


Device Id: 10612479245850

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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