1ST283-100 LuMon™ Belt Size 92

GUDID EIT11ST2831000

SenTec AG

Thoracic electrical impedance system, tomographic

• Primary Device ID: EIT11ST2831000
• NIH Device Record Key: 73affd07-dc62-4b46-ad5f-f0f0495c7e8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1ST283-100 LuMon™ Belt Size 92
• Version Model Number: 1ST283-100
• Company DUNS: 480797856
• Company Name: SenTec 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
HIBCC	EIT11ST2831000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243765

FDA Product Code

• QEB: Ventilatory Electrical Impedance Tomograph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-16
• Device Publish Date: 2025-09-08

Devices Manufactured by SenTec AG

• 07640121881053 - 103583 LuMon™ Contact Gel Kit: 2025-09-16
• EIT11ST1201000 - 1ST120-100 LuMon™ Connector 2.0: 2025-09-16 The LuMon Connector 2.0 is a reusable adapter intended to link a LuMon™ Belt to the LuMon™ Monitor.
• EIT11ST2721000 - 1ST272-100 LuMon™ Belt Size 19: 2025-09-16
• EIT11ST2731000 - 1ST273-100 LuMon™ Belt Size 22: 2025-09-16
• EIT11ST2741000 - 1ST274-100 LuMon™ Belt Size 26: 2025-09-16
• EIT11ST2751000 - 1ST275-100 LuMon™ Belt Size 30: 2025-09-16
• EIT11ST2761000 - 1ST276-100 LuMon™ Belt Size 35: 2025-09-16
• EIT11ST2771000 - 1ST277-100 LuMon™ Belt Size 40: 2025-09-16