Advance Plus

GUDID 10610075101952

Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 8 Fr 16 in, Straight

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter

• Primary Device ID: 10610075101952
• NIH Device Record Key: aaf3b839-b3a8-4bd5-8634-a629baf91b6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advance Plus
• Version Model Number: 94084IC
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 25
• 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

Device Dimensions

• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075101955 [Primary]
GS1	10610075101952 [Package]; Contains: 00610075101955; Package: Case [4 Units]; In Commercial Distribution
GS1	30610075101956 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013483

FDA Product Code

• KOD: CATHETER, UROLOGICAL

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: 2018-12-03
• Device Publish Date: 2016-09-21

On-Brand Devices [Advance Plus]

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• 10610075971449: Closed System Intermittent Catheter Kit, 14 Fr 16 in, Coude
• 10610075971241: Closed System Intermittent Catheter Kit, 12 Fr 16 in, Coude
• 10610075102140: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 18 Fr
• 10610075102133: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 16 Fr
• 10610075102126: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr
• 10610075102119: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr
• 10610075102102: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 10 Fr
• 10610075102096: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 8 Fr
• 10610075102089: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 6 Fr
• 10610075102041: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Coude, 16
• 10610075102034: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Coude, 14
• 10610075102027: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Coude, 12
• 10610075102010: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 18 Fr 16 i
• 10610075101990: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 16 Fr 16 i
• 10610075101983: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 14 Fr 16 i
• 10610075101976: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 12 Fr 16 i
• 10610075101969: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 10 Fr 16 i
• 10610075101952: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 8 Fr 16 in
• 10610075101945: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 6 Fr 16 i
• 30610075971443: Closed System Intermittent Catheter Kit, 14 Fr 16 in, Coude