ENLIGHT 2100

GUDID 07898966433573

ENLIGHT 2100 is a non-invasive, radiation free medical device that provides information from impedance variation from a cross-section of a patient’s thorax. This information is presented to the clinician user as adjunctive tool to other clinical information in order to support the user’s assessment of variations in regional air content within a cross section of a patient’s lungs. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 -134 cm.

Timpel S/A

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• Primary Device ID: 07898966433573
• NIH Device Record Key: bc1fc903-92c4-484a-bdb4-e9bf7d0d1969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENLIGHT 2100
• Version Model Number: TPL-E2103-1
• Company DUNS: 897939320
• Company Name: Timpel S/A
• 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	07898966433573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211135

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: 2022-04-07
• Device Publish Date: 2022-03-30

On-Brand Devices [ENLIGHT 2100]

• 07898966433573: ENLIGHT 2100 is a non-invasive, radiation free medical device that provides information from imp
• 07898966433146: ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local