Apogee

GUDID 10610075069047

Urethral Intermittent Catheter, Coudé Tip

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter

• Primary Device ID: 10610075069047
• NIH Device Record Key: 3dccf708-3079-4866-8ed2-51a0854263a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apogee
• Version Model Number: 11826Q
• 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

Device Dimensions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075069033 [Unit of Use]
GS1	00610075069040 [Primary]
GS1	10610075069047 [Package]; Contains: 00610075069040; Package: Case [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992137

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: 2022-08-19
• Device Publish Date: 2022-08-11

On-Brand Devices [Apogee]

• 10610075177049: Intermittent Catheter, 14 Fr 16 in, Firm, Curved Package, Coude
• 10610075177025: Intermittent Catheter, 14 Fr 16 in, Soft, Curved Package, Straight
• 10610075177001: Intermittent Catheter, 14 Fr 16 in, Curved Package
• 10610075176981: Intermittent Catheter, 12 Fr 16 in, Curved Package, Straight
• 10610075176868: Intermittent Catheter, Latex, 16 Fr 16 in, Straight
• 10610075176851: Intermittent Catheter, Latex, 14 Fr 16 in, Straight
• 10610075176844: Intermittent Catheter, Latex, 12 Fr 16 in, Straight
• 10610075176837: Intermittent Catheter, 10 Fr 16 in, Straight, Soft
• 10610075176776: Intermittent Catheter, 12 Fr 16 in, Soft, Straight
• 10610075176769: Intermittent Catheter, 16 Fr 16 in, Straight, Soft
• 10610075176721: Intermittent Catheter, 14 Fr 16 in, Soft, Straight
• 00610075069002: Urethral Intermittent Catheter, Coudé Tip
• 00610075068999: Urethral Intermittent Catheter, Coudé Tip
• 00610075068968: Urethral Intermittent Catheter, Coudé Tip
• 00610075068944: Urethral Intermittent Catheter, Straight Tip
• 00610075068975: Urethral Intermittent Catheter, Straight Tip
• 00610075068951: Urethral Intermittent Catheter, Straight Tip
• 00610075068937: Urethral Intermittent Catheter, Straight Tip
• 10610075069047: Urethral Intermittent Catheter, Coudé Tip
• 10610075068590: Urethral Intermittent Catheter, Straight Tip
• 10610075068576: Urethral Intermittent Catheter, Straight Tip
• 10610075068538: Urethral Intermittent Catheter, Straight Tip
• 10610075068491: Urethral Intermittent Catheter, Straight Tip
• 20610075177060: Catheter Insertion Kit
• 00610075177042: Intermittent Catheter, 14 Fr 16 in, Firm, Curved Package, Coude
• 00610075177028: Intermittent Catheter, 14 Fr 16 in, Soft, Curved Package, Straight
• 00610075176984: Intermittent Catheter, 12 Fr 16 in, Curved Package, Straight
• 00610075176861: Intermittent Catheter, Latex, 16 Fr 16 in, Straight
• 00610075176854: Intermittent Catheter, Latex, 14 Fr 16 in, Straight
• 00610075176847: Intermittent Catheter, Latex, 12 Fr 16 in, Straight
• 00610075176830: Intermittent Catheter, 10 Fr 16 in, Straight, Soft
• 00610075176779: Intermittent Catheter, 12 Fr 16 in, Soft, Straight
• 00610075176762: Intermittent Catheter, 16 Fr 16 in, Straight, Soft