EmbraceTM Electrodes Array (L)
Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
Record
| Listed by | O.B – Tools Ltd |
|---|---|
| FDA product code | OSP |
| Device type | Uterine Electromyographic Monitor |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2720 |
| Record published | 2017-02-12 |
| Record revised | 2020-01-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep in cool dry place |
| Packaging | Pack of 10 embrace e of 10, 10 packs of 10 arra of 100 |
| Sizes | Width 280 mm; length 320 mm |
| Distribution end date | 2020-01-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG0003(X) | Width 280 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novii | Monica Healthcare | 4 |
| Novii Interface Cable | Datex-Ohmeda, Inc. | 3 |
| Novii | Datex-Ohmeda, Inc. | 2 |
| Monica | Monica Healthcare | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.