Vyaire
Microgard II filter adapter for RPM
7manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Fujian (2), Jiangsu (1). 4 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 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 |
Record
| Listed by | Jaeger Medical GmbH, Germany |
|---|---|
| FDA product code | CAP |
| Device type | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2600 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K940375 |
| Record published | 2019-05-28 |
| Record revised | 2025-05-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 70 °C; Storage environment humidity 10 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 36-ASS1222 | In distribution | |
| 36-MEC1107 | In distribution | |
| 36-RPM01-STK | In distribution | |
| 36-ASS1307 | In distribution | |
| 36-FIL6050 | In distribution | |
| 36-ASS1221 | In distribution | |
| 36-FIL6050A | In distribution | |
| 36-ASS1091 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AincA® | Anesthesia Associates, Inc. | 24 |
| Manometer | Mercury Medical Enterprises, LLC | 18 |
| Jaeger | Jaeger Medical GmbH | 9 |
| Medline Industries, Inc. | Medline Industries, Inc. | 6 |
| Jitto | Galemed Corp. | 6 |
| Napa | DRW Medical | 5 |
| Micro Medical | Jaeger Medical GmbH | 4 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | GE Healthcare Finland OY | 4 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Galemed Corp. | 3 |
| Resuscitator Manometer POP OFF 60cmH2O(PC) | Besmed Health Business Corporation | 2 |
| Cuff Pressure Monitor Assembly | Instrumentation Industries, Incorporated | 2 |
| DPM | Pulmodyne Inc. | 2 |
Showing 12 of 44. All products under Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N83074 | 1985-03-22 | NON-ABSORBABLE BLACK SILK SUTURE | Look, Inc. |
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.