- Physicians Office Resource

Personal Catheter™ Intermittent Catheter Antibacterial Hydrophilic Coated Silicone, Female
Personal Catheter™ Intermittent Catheter - 61514

Device Description

A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Catheter Gauge: 14 French

Catheter Gauge: 14 French

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: MJC

Device Name: Catheter, Urological (Antimicrobial) And Accessories

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: 20801741068991

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10801741068994

Package Quantity: 180

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 10801741068994

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741068997

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741068997

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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