AincA®
Gauge Guard for 00-199, 2.5', 1/2" Back and Bottom Mount, Blue, Alcryn MPR Without Hook and Loop Fastener. Fits 00-199 and related products (LF)
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 | Anesthesia Associates, Inc., 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, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-03-31 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P-219-MRI | In distribution | |
| 00-199-MAX | In distribution | |
| 00-266-G | In distribution | |
| 00-150-BACK | In distribution | |
| 00-199-BACK | In distribution | |
| P-219-1 | In distribution | |
| 00-199-TOP | In distribution | |
| P-158-L | In distribution | |
| 00-276 | In distribution | |
| 00-199-MRI | In distribution | |
| 00-275-MAX | In distribution | |
| P-158 | In distribution | |
| 00-266-G-MAX | In distribution | |
| 00-275 | In distribution | |
| 00-198 | In distribution | |
| P-158-MAX | In distribution | |
| 00-200 | In distribution | |
| 00-196 | In distribution | |
| 00-199 | In distribution | |
| 00-198-1 | In distribution | |
| 00-200-S-MRI | In distribution | |
| 00-200-S | In distribution | |
| 00-195 | In distribution | |
| 00-150 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Manometer | Mercury Medical Enterprises, LLC | 18 |
| 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.