VaPro

GUDID 00610075080595

No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, F-Style, Protective Tip and Sleeve

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter

• Primary Device ID: 00610075080595
• NIH Device Record Key: 31558723-3e01-4964-824b-ee89a6dd864f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VaPro
• Version Model Number: 7600104
• 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: 10 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	00610075061242 [Primary]
GS1	00610075080595 [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]

• 20610075161700: Ready to Use Hydrophilic Intermittent Catheter, 16 Fr 16 in, Coude
• 20610075161694: Ready to Use Hydrophilic Intermittent Catheter, 14 Fr 16 in, Coude
• 20610075161687: Ready to Use Hydrophilic Intermittent Catheter, 12 Fr 16 in, Coude
• 00610075065455: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 00610075065448: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 00610075065431: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 00610075065424: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 00610075065417: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 00610075065400: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 00610075065394: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 00610075065387: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 00610075065370: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 00610075080625: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Tip and Sleeve
• 00610075080618: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, F-Style, Protective Tip and
• 00610075080601: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, F-Style, Protective Tip and
• 00610075080595: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, F-Style, Protective Tip and
• 00610075080588: No Touch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, F-Style, Protective Tip and