VaPro Plus Pocket

GUDID 10610075054005

Ready to Use Hydrophilic Closed System Intermittent Catheter, Compact, 12 Fr 16 in, Straight

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter

• Primary Device ID: 10610075054005
• NIH Device Record Key: 2d178774-8434-425a-8f41-cd97013f5113
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VaPro Plus Pocket
• Version Model Number: 71124-30
• 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: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 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	00610075054008 [Primary]
GS1	10610075054005 [Package]; Contains: 00610075054008; Package: Case [8 Units]; In Commercial Distribution
GS1	20610075054002 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152268

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 Pocket]

• 10610075054074: Ready to Use Hydrophilic Closed System Intermittent Catheter, Compact, 14 Fr 8 in, Straight
• 10610075054067: Ready to Use Hydrophilic Closed System Intermittent Catheter, Compact, 12 Fr 8 in, Straight
• 10610075054050: Ready to Use Hydrophilic Closed System Intermittent Catheter, Compact, 10 Fr 8 in, Straight
• 10610075054043: Ready to Use Hydrophilic Closed System Intermittent Catheter, Compact, 8 Fr 8 in, Straight
• 10610075054036: Ready to Use Hydrophilic Closed System Intermittent Catheter, Compact, 16 Fr 16 in, Straight
• 10610075054012: Ready to Use Hydrophilic Closed System Intermittent Catheter, Compact, 14 Fr 16 in, Straight
• 10610075054005: Ready to Use Hydrophilic Closed System Intermittent Catheter, Compact, 12 Fr 16 in, Straight
• 10610075053992: Ready to Use Hydrophilic Closed System Intermittent Catheter, Compact, 10 Fr 16 in, Straight
• 10610075053985: Ready to Use Hydrophilic Closed System Intermittent Catheter, Compact, 8 Fr 16 in, Straight
• 00610075054077: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075054060: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075054053: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075054046: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075054039: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075054015: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075054008: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075053995: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075053988: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075065332: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 00610075065301: No Touch Urethral Intermittent Catheter with Integrated Collection Bag, Hydrophilic, Straight Ti
• 10610075094483: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 10610075094476: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 10610075094469: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 10610075094445: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 10610075094438: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 10610075094421: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 10610075094407: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 10610075094391: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 10610075094384: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve