IntelliCuff 951001

GUDID 07630002800839

Hamilton Medical AG

Artificial airway tube cuff pressure monitor Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator

• 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

• 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