Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
D-Lite++ Patient Spirometry SET, 2M/7FT, 1 PCS
7manufacturers in China registered for this device type
4catalogue 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 | GE Healthcare Finland OY, Finland |
|---|---|
| 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, Repacker / relabeller, Manufacturer |
| 510(k) | K051092 |
| Record published | 2016-08-15 |
| Record revised | 2025-04-29 (version 10) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Box of 50, pack of 50, pack of 20, box of 20 |
| Distribution end date | 2024-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pedi-lite Spirometry Kit 2m, 8002718 | In distribution | |
| D-lite Spirometry Kit, 3m/10ft | In distribution | |
| D-LITE PATIENT SPIROMETRY SET 2104297-001 | In distribution | |
| D-lite Spirometry Kit 2m 7ft, 8004381 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AincA® | Anesthesia Associates, Inc. | 24 |
| 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) | 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)
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2015-04-24 | Class II | Nonconforming Material/Component | A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. This water trap occlusion could cause a l | 5,018 (US = 2,948 / OUS = 2,070) | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2014-05-23 | Class II | Nonconforming Material/Component | Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. | 4,961 (1,946 units US, 3,015 units OUS) | 2015-10-21 |
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.