Apogee Plus

GUDID 20610075177428

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

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter

• Primary Device ID: 20610075177428
• NIH Device Record Key: 131521f7-6e44-476e-871a-25bed94ecda5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apogee Plus
• Version Model Number: B16RB
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• Labeled No Natural Rubber Latex: false
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10610075177421 [Unit of Use]
GS1	20610075177428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032710

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: 2018-07-06
• Device Publish Date: 2016-09-21

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