IntelliCuff 951001

GUDID 07630002800839

Hamilton Medical AG

Artificial airway tube cuff pressure monitor

• Primary Device ID: 07630002800839
• NIH Device Record Key: b3323140-743c-4d7d-b248-4a67135630cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliCuff
• Version Model Number: 951001
• Catalog Number: 951001
• 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	07630002800839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150893

FDA Product Code

• BSK: Cuff, Tracheal Tube, Inflatable

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: 2018-07-06
• Device Publish Date: 2016-04-13

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