Respiratory Mech Mod,w/accssry
Catalogue number 115-047304-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Transducer, Gas Flow. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Unimed Medical Supplies Inc | Shenzhen | Guangdong | Contract manufacturer | 15 |
Record
| Listed by | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | BXP |
| Device type | Transducer, Gas Flow |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2885 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K182075 |
| Record published | 2020-05-07 |
| Record revised | 2021-11-10 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115-047304-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Flow Sensor | Respironics Novametrix, LLC | 10 |
| Create Biotech | Create Biotech Co., Ltd. | 8 |
| Puritan Bennett | Covidien LP | 2 |
| Infinity ID Flow Sensor | Drägerwerk AG & Co. KGaA | 1 |
| Flow sensor | Honeywell Healthcare Solutions GmbH | 1 |
| Respiratory Mechanics Flow Sensor → Adult/Pediatric | Draeger Medical Systems, Inc. | 1 |
| Spirolog Flow Sensor | Drägerwerk AG & Co. KGaA | 1 |
| SpiroLife | Drägerwerk AG & Co. KGaA | 1 |
| Spiro-SP TrueFlow Sensor | NDD Medizintechnik AG | 1 |
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.