Infyna Chic

GUDID 00610075072712

Hydrophilic, single-use intermittent catheter

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter

• Primary Device ID: 00610075072712
• NIH Device Record Key: d705ad56-b219-444d-85dc-399e830acd8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infyna Chic
• Version Model Number: 8114-30
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 30
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: ccsecurestart@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com

Device Dimensions

• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Length: 5 Inch
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch
• Catheter Gauge: 14 French
• Length: 5.5 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075072675 [Primary]
GS1	00610075072712 [Unit of Use]
GS1	10610075072672 [Package]; Contains: 00610075072675; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191633
• Premarket Notification: K213575

FDA Product Code

• GBM: Catheter, Urethral
• EZD: CATHETER, STRAIGHT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-09
• Device Publish Date: 2021-02-01

On-Brand Devices [Infyna Chic]

• 00610075072712: Hydrophilic, single-use intermittent catheter
• 00610075072705: Hydrophilic, single-use intermittent catheter
• 00610075072682: Hydrophilic, single-use intermittent catheter
• 00610075072644: Hydrophilic, single-use intermittent catheter
• 00610075072699: Hydrophilic, single-use intermittent catheter