TriplePlay
Interface Cable, Perfect Fit Disposable Effort Belt, Alice 5
3manufacturers in China registered for this device type
71catalogue numbers in this listing
1510(k) clearance
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 | Dymedix Diagnostics Inc, United States |
|---|---|
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K990321 |
| Record published | 2016-10-11 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 50, inner pack of 50, inner pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12-40312-0001 | In distribution | |
| 12-20020-0001 | In distribution | |
| 12-40301-0001 | In distribution | |
| 12-10150-0001 | In distribution | |
| 19-20000-0001 | In distribution | |
| 12-40204-0001 | In distribution | |
| 12-40314-0001 | In distribution | |
| 12-40207-0001 | In distribution | |
| 10-14000-0401 | In distribution | |
| 12-40323-0001 | In distribution | |
| 10-40000-0501 | In distribution | |
| 12-40306-0001 | In distribution | |
| 10-10000-0401 | In distribution | |
| 12-10172-0001 | In distribution | |
| 10-21001-0301 | In distribution | |
| 10-14000-0301 | In distribution | |
| 10-10000-0501 | In distribution | |
| 12-10177-0001 | In distribution | |
| 12-40302-0001 | In distribution | |
| 12-40307-0001 | In distribution | |
| 12-10176-0001 | In distribution | |
| 12-10003-0001 | In distribution | |
| 12-40208-0001 | In distribution | |
| 12-10016-0001 | In distribution | |
| 12-40205-0001 | In distribution | |
| 12-40101-0001 | In distribution | |
| 12-10153-0001 | In distribution | |
| 10-41000-0001 | In distribution | |
| 12-10180-0001 | In distribution | |
| 12-10013-0001 | In distribution | |
| 12-40304-0001 | In distribution | |
| 12-40210-0001 | In distribution | |
| 12-40300-0001 | In distribution | |
| 12-10173-0001 | In distribution | |
| 12-40200-0001 | In distribution | |
| 12-10018-0001 | In distribution | |
| 12-40209-0001 | In distribution | |
| 12-40315-0001 | In distribution | |
| 12-40203-0001 | In distribution | |
| 10-10000-0301 | In distribution | |
| 10-10000-0601 | In distribution | |
| 12-40206-0001 | In distribution | |
| 12-40201-0001 | In distribution | |
| 10-15000-0601 | In distribution | |
| 12-40313-0001 | In distribution | |
| 12-40320-0001 | In distribution | |
| 12-20001-0001 | In distribution | |
| 10-21001-0601 | In distribution | |
| 12-10120-0001 | In distribution | |
| 10-10000-0201 | In distribution | |
| 12-40311-0001 | In distribution | |
| 10-10000-0001 | In distribution | |
| 12-30101-0001 | In distribution | |
| 12-10161-0001 | In distribution | |
| 10-14000-0201 | In distribution | |
| 12-10106-0001 | In distribution | |
| 12-40316-0001 | In distribution | |
| 12-10160-0001 | In distribution | |
| 10-14000-0501 | In distribution | |
| 12-40305-0001 | In distribution | |
| 12-40202-0001 | In distribution | |
| 12-10116-0001 | In distribution | |
| 12-20004-0001 | In distribution | |
| 12-40303-0001 | In distribution | |
| 12-10170-0001 | In distribution | |
| 12-40321-0001 | In distribution | |
| 12-10017-0001 | In distribution | |
| 12-10171-0001 | In distribution | |
| 12-40310-0001 | In distribution | |
| 12-10113-0001 | In distribution | |
| 12-40322-0001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sleepsense | S. L. P. Scientific Laboratory Products Ltd | 182 |
| 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 |
| Alice PDx | Respironics Inc. | 17 |
Showing 12 of 259. All products under Ventilatory Effort Recorder
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200654 | 2020-07-22 |
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.