ENLIGHT 1810

Basic Information

• Brand Name: ENLIGHT 1810
• Primary DI: 07898959841415
• Version / Model: TP-ENU00-0
• Company Name: Timpel S/A
• Labeler DUNS: 897939320
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-28
• Public Version: 2
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: a47245bc-0069-4c43-91d1-0d216945adc4

Device Description

"ENLIGHT 1810 is a non-invasive and non-radiation 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 be used with other clinical information to assess the patient’s ventilation. It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm. ENLIGHT1810 and its accessories are prescription use only."

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QEB	Ventilatory Electrical Impedance Tomograph	Anesthesiology	868.1505	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57965	Thoracic electrical impedance system, tomographic	An assembly of devices designed to perform continuous bioimpedance measurements throughout a cross-section of the thorax, to provide real-time feedback of lung function during controlled, assisted or spontaneous ventilation. It typically consists of a mobile trolley, an electrically-powered unit with a monitor and controls, connecting cables, and an electrode chest belt (typically with 16-32 electrodes). The technique [electrical impedance tomography (EIT)] uses single-frequency, low-amplitude alternating current applied by a pair of electrodes whereby the generated electrical potentials at the body surface are continuously measured by other electrodes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07898959841415	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN170072	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity