Foley Catheter

GUDID 10369771001003

Foley Catheter 14fr 30cc

GERI-GENTLE 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 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 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: 10369771001003
• NIH Device Record Key: acf59211-25fb-4d5e-b0a7-32d4a8e86a54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foley Catheter
• Version Model Number: 21-080
• Company DUNS: 361663839
• Company Name: GERI-GENTLE CORPORATION
• Device Count: 1
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00369771001006 [Primary]
GS1	10369771001003 [Package]; Contains: 00369771001006; Package: Inner [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082815

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: 2
• Public Version Date: 2019-07-12
• Device Publish Date: 2019-02-26

On-Brand Devices [Foley Catheter]

• 10369771001133: Foley Catheter 16fr 30cc
• 20369771001123: Foley Catheter 24fr 5cc
• 10369771001119: Foley Catheter 24fr 30cc
• 20369771001093: Foley Catheter 22fr 5cc
• 10369771001089: Foley Catheter 22fr 30cc
• 10369771001072: Foley Catheter 20fr 5cc
• 10369771001065: Foley Catheter 20fr 30cc
• 10369771001058: Foley Catheter 18fr 30cc
• 20369771001048: Foley Catheter 18fr 5cc
• 20369771001031: Foley Catheter 16fr 5cc
• 20369771001017: Foley Catheter 14fr 5cc
• 10369771001003: Foley Catheter 14fr 30cc