Pressure Reducer CGA 580

GUDID 04057607000151

KLS Martin GmbH + Co. KG

Argon-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator Inert gas-enhanced electrosurgical system generator

• Primary Device ID: 04057607000151
• NIH Device Record Key: 90704fd4-d736-4660-b031-c92076fc22e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pressure Reducer CGA 580
• Version Model Number: CB200-A02
• Company DUNS: 340331859
• Company Name: KLS Martin GmbH + Co. KG
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057607000151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081678

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by KLS Martin GmbH + Co. KG

• 04057607000106 - Beamer ESU CE200: 2018-07-06
• 04057607000113 - Beamer Plus CB200: 2018-07-06
• 04057607000120 - Beamer Cart CC200: 2018-07-06
• 04057607000137 - Connecting Cable for Argon Probes: 2018-07-06
• 04057607000144 - Reusable Cable for Neutral Electrodes: 2018-07-06
• 04057607000151 - Pressure Reducer CGA 580: 2018-07-06
• 04057607000151 - Pressure Reducer CGA 580: 2018-07-06
• 04057607000168 - Double Pedal Foot Switch: 2018-07-06
• 04057607000175 - Single Pedal Foot Switch: 2018-07-06