Apogee Plus

GUDID 20610075177442

Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 18 Fr 16 in, Firm, 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 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 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: 20610075177442
• NIH Device Record Key: 7249bec9-49a8-4a69-ab1f-a189e8cf42b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apogee Plus
• Version Model Number: B18FB
• 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: 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

• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch
• Catheter Gauge: 18 French
• Length: 16 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	10610075177445 [Unit of Use]
GS1	20610075177442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032710

FDA Product Code

• FCM: Tray, catheterization, sterile urethral, with or without catheter (kit)
• 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

On-Brand Devices [Apogee Plus]

• 20610075177480: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Firm, Kit,
• 20610075177473: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Firm, 8 Fr
• 20610075177466: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 6 Fr
• 20610075177442: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 18 Fr
• 20610075177435: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 18 Fr 16 i
• 20610075177428: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 16 Fr
• 20610075177411: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 16 Fr 16 i
• 20610075177381: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 16 Fr
• 20610075177374: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 16 Fr 16
• 20610075177343: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr
• 20610075177336: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 14 Fr 16 i
• 20610075177312: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr
• 20610075177305: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr
• 20610075177299: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 14 Fr 16 i
• 20610075177268: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr
• 20610075177220: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr
• 20610075177213: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 12 Fr 16 i
• 20610075177206: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, Firm,
• 20610075177190: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Firm, 10 F
• 20610075177183: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 16 Fr
• 20610075177176: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 16 Fr 16 i
• 20610075177169: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr
• 20610075177152: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 14 Fr 16 i
• 20610075177145: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Firm, 14
• 20610075177138: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr
• 20610075177121: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr
• 20610075177114: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 14 Fr 16 i
• 20610075177107: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr
• 20610075177091: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 12 Fr 16 i
• 20610075177084: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr
• 20610075177077: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, 12 Fr 16 i