Vyaire
36 catalogue numbers from 2.5, listed by Jaeger Medical GmbH, Germany, under Spirometer, Diagnostic. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
36catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Fujian (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Flexible Circuit Technologies Shenzhen | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Feellife Health Inc. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Jaeger Medical GmbH, Germany |
|---|---|
| FDA product code | BZG |
| Device type | Spirometer, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1840 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K141936 |
| Record published | 2019-03-19 |
| Record revised | 2025-05-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature -20 to 70 °C |
| Distribution end date | 2019-05-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.5 | In distribution | |
| 36-TDX1042 | In distribution | |
| 36-PL10-STK/ASIAN | In distribution | |
| 36-ML3500 MK8-Region 4 | In distribution | |
| 36-MFA1010 | In distribution | |
| 36-TDX1050 | In distribution | |
| 36-MS10-STK | In distribution | |
| 36-ML2525-STK | In distribution | |
| 36-PL10-STK/ECCS | In distribution | |
| 36-ASS1270 | In distribution | |
| 36-ML3500 MK8-STK | In distribution | |
| 2.5 | In distribution | |
| 36-MLD1621 | In distribution | |
| 5.7 | In distribution | |
| 36-TDX1048 | In distribution | |
| 36-MFA1050 | In distribution | |
| 36-PL10-STK/NHANES | In distribution | |
| 36-TDX1050 | In distribution | |
| 36-ML3535 MK8-Region 2&3 | In distribution | |
| 36-TDX1043 | In distribution | |
| 36-MD03-STK | In distribution | |
| 36-MLD1621 | In distribution | |
| 36-MFA1050 | In distribution | |
| 36-TDX1043 | In distribution | |
| 2.5 | In distribution | |
| 36-ML3535 MK8-Region 4 | In distribution | |
| 36-ML3500 MK8-Region 2&3 | In distribution | |
| 36-TDX1051 | In distribution | |
| 36-ASS1270 | In distribution | |
| 36-TDX1051 | In distribution | |
| 36-MLD1587 | In distribution | |
| 2.5 | In distribution | |
| 36-ML3535 MK8-STK | In distribution | |
| 5.7 | In distribution | |
| 36-TDX1048 | In distribution | |
| 36-PSA1100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Polytech Filter | Polytechnic Resources, Inc. | 190 |
| Model 4000 | Vitalograph Ireland Ltd. | 115 |
| Astra Spirometer | S D I Diagnostics Inc | 90 |
| MIR | Mir Medical International Research | 56 |
| Curaplex | TRI-Anim Health Services, Inc. | 55 |
| Alpha | Vitalograph Ireland Ltd. | 48 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 47 |
| MGC Diagnostics | Medical Graphics Corp. | 42 |
| Astraguard | S D I Diagnostics Inc | 39 |
| PFT | Vitalograph Ireland Ltd. | 38 |
| BVF | Vitalograph Ireland Ltd. | 29 |
| Micro Medical | Jaeger Medical GmbH | 25 |
Showing 12 of 123. All products under Spirometer, Diagnostic
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.