HAMILTON-C6 160021

GUDID 07630002808590

Hamilton Medical AG

Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator

• Primary Device ID: 07630002808590
• NIH Device Record Key: 12ba50f2-2d69-41d7-9d5d-a7cf453d14d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAMILTON-C6
• Version Model Number: 160021
• Catalog Number: 160021
• Company DUNS: 481492312
• Company Name: Hamilton Medical AG
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	07630002808590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201658

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-03
• Device Publish Date: 2022-01-26

Devices Manufactured by Hamilton Medical AG

• 07630002808590 - HAMILTON-C6: 2022-02-03
• 07630002808590 - HAMILTON-C6: 2022-02-03
• 07630002813426 - HAMILTON-C1: 2022-02-03
• 07630002813532 - HAMILTON-T1: 2022-02-03
• 07630002813549 - HAMILTON-T1: 2022-02-03
• 07630002813556 - HAMILTON-MR1: 2022-02-03
• 07630002800013 - HAMILTON-G5: 2020-01-13
• 07630002800846 - HAMILTON-BC8010: 2019-11-27 HAMILTON-BC8010, breathing circuit set, dual limb, heated, with water chamber
• 07630002801416 - HAMILTON-BC4010: 2019-11-27 HAMILTON-BC4010, breathing circuit set, single limb, heated, with water chamber