Novii
Novii Wireless Patch System (GEHC)
1manufacturer
4catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
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 | Monica Healthcare, United Kingdom |
|---|---|
| FDA product code | OSP |
| Device type | Uterine Electromyographic Monitor |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2720 |
| Record published | 2016-09-12 |
| Record revised | 2025-04-08 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature 10 to 30 °C; Handling environment temperature 10 to 30 °C |
| Packaging | Carton, box, carton of 3, carton of 2 |
| Distribution end date | 2022-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 107-PT-001 | Withdrawn | |
| 107-PT-020 | Withdrawn | |
| 107-PT-003 | Withdrawn | |
| 107-PT-002-US | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novii Interface Cable | Datex-Ohmeda, Inc. | 3 |
| Novii | Datex-Ohmeda, Inc. | 2 |
| EmbraceTM Electrodes Array (L) | O.B – Tools Ltd | 1 |
| Monica | Monica Healthcare | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140862 | 2014-08-27 |
| K112390 | 2012-07-13 |
| K112163 | 2011-08-30 |
| K101801 | 2011-02-03 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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.