FDA UDI
In Commercial Distribution
🇺🇸 United States
ENLIGHT BELT – P1 – RIGHT
DI: 07898966433429
·
Model: ACE-00046
·
Timpel S/A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENLIGHT BELT – P1 – RIGHT
- Primary DI
- 07898966433429
- Version / Model
- ACE-00046
- Company Name
- Timpel S/A
- Labeler DUNS
- 897939320
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-30
- Public Version
- 2
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- eee092f8-bd85-4d53-9c76-082272f533f6
Device Description
The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT. Disposable. Non-sterile and not to be sterilized. It must be used with Addere
Device Characteristics
- Single Use
- Yes
- 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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| 61679 | Thoracic electrical impedance electrode array, single-use | A noninvasive configuration of multiple electrodes (e.g., patches, belt-like) intended to be affixed to the thorax to perform continuous bioimpedance measurements for assessment of lung function (e.g., respiratory rate) or pulmonary conditions (e.g., atelectasis, pneumothorax, endotracheal tube misplacement) of a ventilated or spontaneous breathing patient; it is intended to be used in conjunction with a parent device [e.g., monitor, thoracic electrical impedance tomography (EIT) or segmentography system]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898966433429 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211135 | 000 |