FDA UDI
In Commercial Distribution
🇺🇸 United States
ENLIGHT ELECTRODE ADDERE - SIZE L
DI: 07898966433283
·
Model: ACE-00033
·
Timpel S/A
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- ENLIGHT ELECTRODE ADDERE - SIZE L
- Primary DI
- 07898966433283
- Version / Model
- ACE-00033
- Company Name
- Timpel S/A
- Labeler DUNS
- 897939320
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2021-05-10
- Public Version
- 3
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- 0711d13f-20d8-4dea-86a1-9223b16a33e8
Device Description
Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with Electrode Belts. Non-sterile and not to be sterilized.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 64408 | Thoracic electrical impedance electrode array conductive skin adhesive tape | A flat, flexible tape with an electrical conductive medium (gel) designed to be used during thoracic electrical impedance (bioimpedance) tomography (EIT) or segmentography to adhere an electrode array (typically belt-like) to the skin surface, and to function as a body-electrode interface to enable continuous bioimpedance measurements. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 07898959841767 | GS1 | ||||
| Primary | 07898966433283 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN170072 | 000 |