FDA UDI
In Commercial Distribution
🇺🇸 United States
ENLIGHT 2100
DI: 07898966433146
·
Model: TPL-E2103-0
·
Timpel S/A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENLIGHT 2100
- Primary DI
- 07898966433146
- Version / Model
- TPL-E2103-0
- Company Name
- Timpel S/A
- Labeler DUNS
- 897939320
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-20
- Public Version
- 2
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- 39e74d5c-8ea6-4371-9d53-674757b3bfb7
Device Description
ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient’s thorax. This information is presented to the clinician user as an 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 patients in a hospital setting, whose thorax perimeter is within the range of 78 -122 cm.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 | 07898966433146 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN170072 | 000 |