FOLEY CATHETER 2-WAY 1210106

GUDID 04544050056243

Foley Catheter is applied to a dysuria, uroschesis patient for urine drainage from bladder.

FUJI SYSTEMS CORPORATION

Indwelling urethral drainage catheter Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial

• Primary Device ID: 04544050056243
• NIH Device Record Key: a219d6aa-7684-492e-aca9-7fe8832e709a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOLEY CATHETER 2-WAY
• Version Model Number: FR.6 - 1.5ML
• Catalog Number: 1210106
• Company DUNS: 715919973
• Company Name: FUJI SYSTEMS CORPORATION
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04544050056243 [Primary]
GS1	14544050056243 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894883

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2018-09-24
• Device Publish Date: 2015-09-24

Devices Manufactured by FUJI SYSTEMS CORPORATION

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• 14544050123836 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123843 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123850 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123867 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123874 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123881 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123898 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve