Cure Pocket Coude™

GUDID 20815947020158

Sterile Intermittent Catheter with Lubricant Packet, Coudé Tip

CURE MEDICAL LLC

Single-administration urethral drainage catheter

• Primary Device ID: 20815947020158
• NIH Device Record Key: 6f819684-6fde-4e5d-9546-664769fa5c01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cure Pocket Coude™
• Version Model Number: M12ULC
• Company DUNS: 070643426
• Company Name: CURE MEDICAL LLC
• Device Count: 1
• 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: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com

Device Dimensions

• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815947020154 [Primary]
GS1	10815947020151 [Package]; Contains: 00815947020154; Package: Box [30 Units]; In Commercial Distribution
GS1	20815947020158 [Package]; Contains: 10815947020151; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072539

FDA Product Code

• GBM: Catheter, Urethral

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-30

On-Brand Devices [Cure Pocket Coude™]

• 20815947020172: Sterile Intermittent Catheter with Lubricant Packet, Coudé Tip
• 20815947020165: Sterile Intermittent Catheter with Lubricant Packet, Coudé Tip
• 20815947020158: Sterile Intermittent Catheter with Lubricant Packet, Coudé Tip
• 00815947020147: Sterile Intermittent Catheter with Lubricant Packet, Coudé Tip