High Pressure Luer Lock Set, Single Lumen 300mmHg

GUDID 20860936000345

THERMEDX, LLC

Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system

• Primary Device ID: 20860936000345
• NIH Device Record Key: 1ff34655-34a0-4e50-b4cc-06148d5006c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: High Pressure Luer Lock Set, Single Lumen 300mmHg
• Version Model Number: HLL003
• Company DUNS: 022465035
• Company Name: THERMEDX, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Pressure: 400 millibar
• Pressure: 400 millibar
• Pressure: 400 millibar
• Pressure: 400 millibar
• Pressure: 400 millibar
• Pressure: 400 millibar
• Pressure: 400 millibar
• Pressure: 400 millibar
• Pressure: 400 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860936000341 [Primary]
GS1	20860936000345 [Package]; Contains: 00860936000341; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091939

FDA Product Code

• HRX: Arthroscope

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: 2016-09-23

Devices Manufactured by THERMEDX, LLC

• 00860936000310 - Fluid Management System: 2018-07-06
• 00860936000327 - Fluid Management System: 2018-07-06
• 20860936000338 - Luer Lock Set, Single Lumen: 2018-07-06
• 20860936000345 - High Pressure Luer Lock Set, Single Lumen 300mmHg: 2018-07-06
• 20860936000345 - High Pressure Luer Lock Set, Single Lumen 300mmHg: 2018-07-06
• 20860936000352 - Tubing Set - Single Lumen, Inflow with Dual Outflow: 2018-07-06
• 20860936000369 - Urology Set: 2018-07-06 Urology Set