Novii
Novii Interface
1manufacturer
2catalogue numbers in this listing
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 | Datex-Ohmeda, Inc., United States |
|---|---|
| FDA product code | OSP |
| Device type | Uterine Electromyographic Monitor |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2720 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K140862 |
| Record published | 2019-01-29 |
| Record revised | 2025-05-07 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| POD 107-PT-003 | In distribution | |
| Interface 107-PT-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novii | Monica Healthcare | 4 |
| Novii Interface Cable | Datex-Ohmeda, Inc. | 3 |
| EmbraceTM Electrodes Array (L) | O.B – Tools Ltd | 1 |
| Monica | Monica Healthcare | 1 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2017-12-15 | Class II | Device Design | if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped). | 1742 | 2020-04-21 |
| Monica Healthcare | 510(k) number | 2017-04-28 | Class II | Nonconforming Material/Component | Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging. | 4,110 (4,106 US; 4 OUS) | 2018-03-01 |
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.