HAMILTON-G5 159001

GUDID 07630002800013

Hamilton Medical AG

Neonatal/adult intensive-care ventilator

• Primary Device ID: 07630002800013
• NIH Device Record Key: 5924a3aa-ab69-4c4e-815e-c3d1c7931282
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAMILTON-G5
• Version Model Number: 159001
• Catalog Number: 159001
• 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: 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	07630002800013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131774

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-13
• Device Publish Date: 2015-10-21

On-Brand Devices [HAMILTON-G5]

• 07630002800013: 159001
• 07630002802208: 5900