Kumar Catheter® CC-019

GUDID B361CC0190

The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to provide a means of laparoscopic cholangiography. It comprises

NASHVILLE SURGICAL INSTRUMENTS, LLC

Laparoscopic cholangiography catheter/needle

• Primary Device ID: B361CC0190
• NIH Device Record Key: b243bd66-2330-4f16-ad1a-0f037f481d94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kumar Catheter®
• Version Model Number: CC019
• Catalog Number: CC-019
• Company DUNS: 030096122
• Company Name: NASHVILLE SURGICAL INSTRUMENTS, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com
• Phone: 615-382-4996
• Email: orders@nashvillesurg.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 45 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B361CC0190 [Primary]
HIBCC	B361CC0191 [Package]; Package: Box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973621

FDA Product Code

• GBZ: Catheter, Cholangiography

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: 2017-08-15

Devices Manufactured by NASHVILLE SURGICAL INSTRUMENTS, LLC

• B361CC0190 - Kumar Catheter®: 2018-07-06The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to provide a means of laparoscopic cholangiography. It comprises
• B361CC0190 - Kumar Catheter®: 2018-07-06 The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to provide a means of laparoscopic cholan
• B361KC0020 - Kumar Clamp®: 2018-07-06 The Kumar Clamp® is a reusable 5mm stainless steel laparoscopic grasper of 37 cm length with long ( 3.8 cm) atraumatic jaws and
• B361KC2XL0 - Kumar Clamp® for Single Port, Bariatrics and Robot: 2018-07-06 The Kumar Clamp® for Single Port, Bariatrics and Robotics is a reusable 5mm stainless steel laparoscopic grasper of 45 cm lengt
• B361TA0080 - Kumar T-ANCHORS® Hernia Set: 2018-07-06 The Kumar T-ANCHORS® Hernia Set provides a means of Fixation of the Mesh in Laparoscopic or Open Repair of Abdominal Wall Herni