VaPro Plus

GUDID 00610075080649

No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Tip, F-Style, Protective Tip and Sleeve

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter

• Primary Device ID: 00610075080649
• NIH Device Record Key: 4c848a32-d38f-4a35-816a-4729c4b1d46f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VaPro Plus
• Version Model Number: 7700144
• 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: true
• 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

Device Dimensions

• Catheter Gauge: 14 French
• Length: 16 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075061334 [Primary]
GS1	00610075080649 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141642

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: 2022-10-10
• Device Publish Date: 2022-09-30

On-Brand Devices [VaPro Plus]

• 10610075176219: Ready to Use Hydrophilic Closed System Intermittent Catheter, 14 Fr 8 in, Straight
• 10610075176202: Ready to Use Hydrophilic Closed System Intermittent Catheter, 12 Fr 8 in, Straight
• 10610075176141: Ready to Use Hydrophilic Closed System Intermittent Catheter, 14 Fr 16 in, Straight
• 10610075176134: Ready to Use Hydrophilic Closed System Intermittent Catheter, 12 Fr 16 in, Straight
• 00610075176212: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075176205: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075176144: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075176137: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075080649: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075080632: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti