Ventilair II 155601

GUDID 07630002800358

Hamilton Medical AG

Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor Medical device air compressor

• Primary Device ID: 07630002800358
• NIH Device Record Key: 05eec05d-c9ec-44ac-9346-7d70b14df188
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ventilair II
• Version Model Number: 155601
• Catalog Number: 155601
• 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	07630002800358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041781

FDA Product Code

• BTI: Compressor, Air, Portable

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: 2015-10-21

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