Manometer
18 catalogue numbers from 10-55350, listed by Mercury Medical Enterprises, LLC, United States, under Monitor, Airway Pressure (Includes Gauge And/Or Alarm). 7 manufacturers in China are registered for this product code.
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 | Mercury Medical Enterprises, LLC, United States |
|---|---|
| FDA product code | CAP |
| Device type | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2600 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K954486 |
| Record published | 2016-05-06 |
| Record revised | 2020-04-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 20, pack of 280, pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-55350 | In distribution | |
| 10-55367 | In distribution | |
| 10-55366 | In distribution | |
| 10-55381 | In distribution | |
| 10-55358 | In distribution | |
| 10-55379 | In distribution | |
| 10-55351 | In distribution | |
| 10-55356 | In distribution | |
| 10-55354 | In distribution | |
| 10-55378 | In distribution | |
| 10-55382 | In distribution | |
| 10-55353 | In distribution | |
| 10-55357 | In distribution | |
| 10-55364 | In distribution | |
| 10-55377 | In distribution | |
| 10-55352 | In distribution | |
| 10-55359 | In distribution | |
| 10-55365 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AincA® | Anesthesia Associates, Inc. | 24 |
| Jaeger | Jaeger Medical GmbH | 9 |
| Vyaire | Jaeger Medical GmbH | 8 |
| 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.