SentrySuite
SentrySuite Software
1manufacturer
1catalogue number
1recall
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | Jaeger Medical GmbH, Germany |
|---|---|
| FDA product code | BZC |
| Device type | Calculator, Pulmonary Function Data |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1880 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K150810 |
| Record published | 2017-11-17 |
| Record revised | 2025-05-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
| Distribution end date | 2020-07-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.21 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jaeger | Jaeger Medical GmbH | 227 |
| Vyaire | Jaeger Medical GmbH | 120 |
| Vyntus | Jaeger Medical GmbH | 14 |
| Innocor | Innovision Medical Technologies, LLC | 6 |
| Vyntus | Vyaire Medical, Inc. | 3 |
| Cosmed | C O S M E D SRL | 3 |
| APS-Pro SA | Jaeger Medical GmbH | 3 |
| MGC Diagnostics | Medical Graphics Corp. | 2 |
| TransAir3 | Medi Soft SA | 1 |
| MasterScreen PFT | Jaeger Medical GmbH | 1 |
| Respiratory Mechanics Sensor → Neonatal | Draeger Medical Systems, Inc. | 1 |
| SentrySuite Software | Jaeger Medical GmbH | 1 |
Showing 12 of 19. All products under Calculator, Pulmonary Function Data
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Jaeger Medical GmbH | 510(k) number | 2024-04-08 | Class I | Process control | Potential of the nozzle separating during patient use. | 649 devices |
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.