HAMILTON-H900 950004

GUDID 07630002801546

Hamilton Medical AG

Heated respiratory humidifier

• Primary Device ID: 07630002801546
• NIH Device Record Key: 5f7c64c9-b9f0-436d-bea2-265d49cf2187
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAMILTON-H900
• Version Model Number: 950004
• Catalog Number: 950004
• 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	07630002801546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152029

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

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: 2016-09-27

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