VaPro Plus

GUDID 10610075176202

Ready to Use Hydrophilic Closed System Intermittent Catheter, 12 Fr 8 in, Straight

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter

• Primary Device ID: 10610075176202
• NIH Device Record Key: 1a36670e-162d-4e8b-a5de-9e37589bf442
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VaPro Plus
• Version Model Number: 74122-30
• 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: 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
• 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

• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075176205 [Primary]
GS1	10610075176202 [Package]; Contains: 00610075176205; Package: Case [8 Units]; In Commercial Distribution
GS1	20610075176209 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

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
• 10610075092762: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 10610075092755: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 10610075092748: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 10610075092731: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 10610075092724: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 10610075092717: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti