Ventilatory Effort Recorder
Adult Nasal High Performance Sensor Cannula 7 1/4" Connect Tubing P/N: 29-4401 Disposable Single Patient Use Only. Note: incorrect DI, see ABM SO number for 5530-0, reference.
3manufacturers in China registered for this device type
4catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Fujian (1), Jiangsu (1), Guangdong (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 |
|---|---|---|---|---|
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
Record
| Listed by | Salter Labs, United States |
|---|---|
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K151874 |
| Record published | 2016-11-30 |
| Record revised | 2020-07-27 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Special storage condition: N/A; Handling environment temperature 5 to 40 °C; Storage environment temperature -40 to 60 °C |
| Packaging | Pack of 25, pack of 10 |
| Distribution end date | 2020-07-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SO-1971 | Adult | In distribution |
| 5055-7 | Pediatric | In distribution |
| M041622-0 | Adult | In distribution |
| SO-1990 | Adult | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sleepsense | S. L. P. Scientific Laboratory Products Ltd | 182 |
| TriplePlay | Dymedix Diagnostics Inc | 71 |
| Embla | S. L. P. Scientific Laboratory Products Ltd | 36 |
| Grass | S. L. P. Scientific Laboratory Products Ltd | 31 |
| Xltek | Embla Systems | 30 |
| Alice NightOne | Respironics Inc. | 22 |
| Onera STS | Onera B.V. | 21 |
| Natus | S. L. P. Scientific Laboratory Products Ltd | 21 |
| Night Shift | Advanced Brain Monitoring, Inc. | 19 |
| Neurovirtual | Neurovirtual USA, Inc. | 18 |
| SOMNOtouch Resp accessory | Somnomedics AG | 18 |
| zRIP | Respironics Inc. | 17 |
Showing 12 of 259. All products under Ventilatory Effort Recorder
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151874 | 2016-04-15 |
| K051313 | 2005-09-15 |
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.