Nonin
Non-Adhesive, Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology
5manufacturers in China registered for this device type
30catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Sichuan (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Nonin Medical, Inc., United States |
|---|---|
| FDA product code | MUD |
| Device type | Oximeter, Tissue Saturation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K090807 |
| Record published | 2016-08-24 |
| Record revised | 2020-12-01 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -22 to 158 °F; Storage environment temperature -30 to 70 °C |
| Packaging | Box, bag, box of 20, box of 10, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X-100SP-2 | In distribution | |
| 7600 | In distribution | |
| 7600PA INT C Lock | In distribution | |
| X-100SP-5 | In distribution | |
| X-100SP-1 | In distribution | |
| X-100SP-3 | In distribution | |
| 8204CA | Pediatric | In distribution |
| X-100HH | In distribution | |
| INT-100 | In distribution | |
| 7600TC-3 | In distribution | |
| 7600TC-2A | In distribution | |
| 8004CB-NA | Neonate | In distribution |
| INT-2XX | Pediatric | In distribution |
| 8000CA | Adult | In distribution |
| 7600TC-3 | In distribution | |
| 8003CA | Adult | In distribution |
| 8003CA | Adult | In distribution |
| 8004CB | Neonate | In distribution |
| 7600 | In distribution | |
| X-100 | In distribution | |
| 8004CA | In distribution | |
| 7600TC-2 | In distribution | |
| X-100H | In distribution | |
| X-100SP-4 | In distribution | |
| 7600PA Sensor Lock | In distribution | |
| 7600 TC-1 | In distribution | |
| 7600PA | In distribution | |
| 7600 | In distribution | |
| X-100SP-6 | In distribution | |
| Sense PMC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invos | Covidien LP | 54 |
| Fore-Sight Elite® | Cas Medical Systems, Inc. | 12 |
| Fore-Sight® | Cas Medical Systems, Inc. | 9 |
| ForeSight | Edwards Lifesciences Technology Sarl | 7 |
| Spectros T-Stat | Spectros Corporation | 7 |
| Component Neuromonitoring System | Moberg Research, Inc. | 6 |
| HyperView | Hypermed Imaging, Inc. | 6 |
| O3 | Masimo Corporation | 5 |
| Mespere | Mespere Lifesciences Inc. | 3 |
| SnapshotNIR | Kent Imaging Inc | 2 |
| Moor Instruments Ltd | Moor Instruments Ltd. | 2 |
| T.Ox SS Sensor | Vioptix, Inc. | 1 |
Showing 12 of 30. All products under Oximeter, Tissue Saturation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190560 | 2019-05-02 |
| K151305 | 2015-08-27 |
| K113215 | 2012-05-14 |
| K102715 | 2010-12-17 |
| K090807 | 2009-06-30 |
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 |
|---|---|---|---|---|---|---|---|
| Nonin Medical, Inc. | 510(k) number | 2014-11-25 | Class II | Nonconforming Material/Component | Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or il | 5892 (5452 US, 440 OUS) | 2015-09-01 |
| Nonin Medical, Inc. | 510(k) number | 2009-10-23 | Not classified | Device Design | A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact wi | 62 | 2012-03-29 |
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.