HAMILTON-BC8010 260185

GUDID 07630002800846

HAMILTON-BC8010, breathing circuit set, dual limb, heated, with water chamber

Hamilton Medical AG

Ventilator breathing circuit, single-use

• Primary Device ID: 07630002800846
• NIH Device Record Key: 4cfd8067-72a4-444f-b9ce-de4620bf38e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAMILTON-BC8010
• Version Model Number: 260185
• Catalog Number: 260185
• Company DUNS: 481492312
• Company Name: Hamilton Medical AG
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com
• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com
• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com
• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com
• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com
• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com
• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com
• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com
• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com
• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com
• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com
• Phone: (775) 858-3200
• Email: info@hamiltonmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630002800846 [Primary]
GS1	17630002800843 [Package]; Package: [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152029

FDA Product Code

• BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-10-04

Devices Manufactured by Hamilton Medical AG

• 07630002800754 - HAMILTON-T1: 2024-08-29
• 07630002802208 - HAMILTON-G5: 2024-08-29 5900
• 07630002800730 - HAMILTON-C2: 2024-08-28
• 07630002802222 - HAMILTON-C3: 2024-08-28
• 07630002808590 - HAMILTON-C6: 2022-02-03
• 07630002813426 - HAMILTON-C1: 2022-02-03
• 07630002813532 - HAMILTON-T1: 2022-02-03
• 07630002813549 - HAMILTON-T1: 2022-02-03