Cystosure

GUDID 00866403000203

Cystosure XL, 16 Fr, silicone catheter

EMMY MEDICAL LLC

Indwelling urethral drainage catheter

• Primary Device ID: 00866403000203
• NIH Device Record Key: 2d8ff963-1d89-4532-ae08-ed73b9d977ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cystosure
• Version Model Number: 10-600
• Company DUNS: 052321836
• Company Name: EMMY 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: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com
• Phone: 7758007300
• Email: ron@cystosure.com

Device Dimensions

• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866403000203 [Primary]
GS1	10866403000200 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	20866403000207 [Package]; Contains: 10866403000200; Package: ShippingCarton [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172422

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

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: 2019-07-12
• Device Publish Date: 2019-05-28

On-Brand Devices [Cystosure]

• 00866403000265: Cystosure Scope, 30 deg, 2.7 mm OD, 270 mm long
• 00866403000234: Scope, 70 deg, 2.7 mm, long (270mm)
• 00866403000210: 16Fr Cystosure Plus, 16Fr, silicone catheter
• 00866403000203: Cystosure XL, 16 Fr, silicone catheter