Onli

GUDID 10610075072368

Hydrophilic Urethral Intermittent Catheter, Straight

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter

• Primary Device ID: 10610075072368
• NIH Device Record Key: 816a8b3d-8d58-4f87-9e2e-1563d56be8cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Onli
• Version Model Number: 82101
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 30
• DM Exempt: true
• 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: 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

• Length: 7 Inch
• Catheter Gauge: 10 French
• Length: 7 Inch
• Catheter Gauge: 10 French
• Length: 7 Inch
• Catheter Gauge: 10 French
• Length: 7 Inch
• Catheter Gauge: 10 French
• Length: 7 Inch
• Catheter Gauge: 10 French
• Length: 7 Inch
• Catheter Gauge: 10 French
• Length: 7 Inch
• Catheter Gauge: 10 French
• Length: 7 Inch
• Catheter Gauge: 10 French
• Length: 7 Inch
• Catheter Gauge: 10 French
• Length: 7 Inch
• Catheter Gauge: 10 French
• Length: 7 Inch
• Catheter Gauge: 10 French
• Length: 7 Inch
• Catheter Gauge: 10 French

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075072361 [Primary]
GS1	00610075072873 [Unit of Use]
GS1	10610075072368 [Package]; Contains: 00610075072361; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211436

FDA Product Code

• GBM: CATHETER, URETHRAL

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: 2022-05-30
• Device Publish Date: 2022-05-20

On-Brand Devices [Onli]

• 20610075056334: Ready to Use Hydrophilic Intermittent Catheter, 14 Fr 6.7 in/17cm, Straight
• 20610075056327: Ready to Use Hydrophilic Intermittent Catheter, 12 Fr 6.7 in/17cm, Straight
• 20610075056310: Ready to Use Hydrophilic Intermittent Catheter, 10 Fr 6.7 in/17cm, Straight
• 20610075056303: Ready to Use Hydrophilic Intermittent Catheter, 08 Fr 6.7 in/17cm, Straight
• 20610075056280: Ready to Use Hydrophilic Intermittent Catheter, 18 Fr 16 in/40cm, Straight
• 20610075056273: Ready to Use Hydrophilic Intermittent Catheter, 16 Fr 16 in/40cm, Straight
• 20610075056266: Ready to Use Hydrophilic Intermittent Catheter, 14 Fr 16 in/40cm, Straight
• 20610075056259: Ready to Use Hydrophilic Intermittent Catheter, 12 Fr 16 in/40cm, Straight
• 20610075056242: Ready to Use Hydrophilic Intermittent Catheter, 10 Fr 16 in/40cm, Straight
• 20610075056235: Ready to Use Hydrophilic Intermittent Catheter, 08 Fr 16 in/40cm, Straight
• 10610075072443: Hydrophilic Urethral Intermittent Catheter, Straight; with Gripper
• 10610075072436: Hydrophilic Urethral Intermittent Catheter, Straight; with Gripper
• 10610075072429: Hydrophilic Urethral Intermittent Catheter, Straight; with Gripper
• 10610075072412: Hydrophilic Urethral Intermittent Catheter, Straight; with Gripper
• 10610075072405: Hydrophilic Urethral Intermittent Catheter, Straight; with Gripper
• 10610075072399: Hydrophilic Urethral Intermittent Catheter, Straight
• 10610075072382: Hydrophilic Urethral Intermittent Catheter, Straight
• 10610075072368: Hydrophilic Urethral Intermittent Catheter, Straight
• 10610075072351: Hydrophilic Urethral Intermittent Catheter, Straight
• 00610075061914: Ready to Use Hydrophilic Intermittent Catheter, 12 Fr 6.7 in/17cm, Straight
• 00610075060658: Ready to Use Hydrophilic Intermittent Catheter, 12 Fr 16 in/40cm, Straight