Vyaire
Elbow 45°, ID 30 mm, ULTEM, especially resistant against disinfection
1manufacturer
120catalogue numbers in this listing
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) | K122699 |
| Record published | 2019-06-04 |
| Record revised | 2025-09-24 (version 5) |
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 50 °C; Storage environment humidity 15 to 95 % RH |
| Distribution end date | 2025-10-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V-861078 | In distribution | |
| V-707325 | In distribution | |
| V-707326 | In distribution | |
| 706169 | In distribution | |
| 707238 | In distribution | |
| V-178602 | In distribution | |
| v-178001-13 | In distribution | |
| V-859143 | In distribution | |
| V-178600-13 | In distribution | |
| 3.20 | In distribution | |
| 707231 | In distribution | |
| 706143 | In distribution | |
| V-707311 | In distribution | |
| 852353 | In distribution | |
| V-178500 | In distribution | |
| 700096 | In distribution | |
| V-707744 | In distribution | |
| 706854 | In distribution | |
| V-859141-13 | In distribution | |
| V-707380 | In distribution | |
| V-707388 | In distribution | |
| V-707327 | In distribution | |
| 852360 | In distribution | |
| 707226 | In distribution | |
| V-841234 | In distribution | |
| V-707717 | In distribution | |
| 705417 | In distribution | |
| V-861732 | In distribution | |
| V-707746 | In distribution | |
| V-707311-13 | In distribution | |
| V-859215 | In distribution | |
| 707146 | In distribution | |
| V-707725 | In distribution | |
| 2.21 | In distribution | |
| V-577084-13 | In distribution | |
| 707230 | In distribution | |
| V-707716 | In distribution | |
| 705388 | In distribution | |
| 711007 | In distribution | |
| 3.10 | In distribution | |
| 705675 | In distribution | |
| V-859142-13 | In distribution | |
| V-577400-13 | In distribution | |
| 720274 | In distribution | |
| V-707343 | In distribution | |
| 705562 | In distribution | |
| 707231 | In distribution | |
| 706133 | In distribution | |
| V-707288 | In distribution | |
| V-852556 | In distribution | |
| 706134 | In distribution | |
| V-707722 | In distribution | |
| 982094 | In distribution | |
| V-707708 | In distribution | |
| V-178603 | In distribution | |
| 3.30 | In distribution | |
| 707238 | In distribution | |
| 707225 | In distribution | |
| 706169 | In distribution | |
| V-707540 | In distribution | |
| V-707721 | In distribution | |
| V-892650 | In distribution | |
| V-707311-13 | In distribution | |
| 2.15 | In distribution | |
| V-707723 | In distribution | |
| V-859140-13 | In distribution | |
| V-178601 | In distribution | |
| V-707390 | In distribution | |
| 709705N | In distribution | |
| V-375610 | In distribution | |
| V-707377 | In distribution | |
| V-835490 | In distribution | |
| V-707960 | In distribution | |
| V-178500-13 | In distribution | |
| V-378540 | In distribution | |
| 711007 | In distribution | |
| V-707311 | In distribution | |
| V-707332 | In distribution | |
| V-707277 | In distribution | |
| 706823 | In distribution | |
| 3.0 | In distribution | |
| 2.19 | In distribution | |
| V-707389 | In distribution | |
| 706132 | In distribution | |
| V-707759 | In distribution | |
| 706188 | In distribution | |
| V-707381 | In distribution | |
| 706175N | In distribution | |
| 706943 | In distribution | |
| V-707392 | In distribution | |
| 706265 | In distribution | |
| 706135 | In distribution | |
| 705048 | In distribution | |
| V-707307 | In distribution | |
| 707226 | In distribution | |
| 982082 | In distribution | |
| V-707290 | In distribution | |
| 705445 | In distribution | |
| 709705N | In distribution | |
| 707230 | In distribution | |
| 852828 | In distribution | |
| 707225 | In distribution | |
| V-707329 | In distribution | |
| v-178001-13 | In distribution | |
| 706132 | Withdrawn | |
| V-707290 | Withdrawn | |
| 705417 | Withdrawn | |
| 706135 | Withdrawn | |
| 706133 | Withdrawn | |
| V-861732 | Withdrawn | |
| 720274 | Withdrawn | |
| V-708052 | Withdrawn | |
| V-707708 | Withdrawn | |
| 982082 | Withdrawn | |
| 706134 | Withdrawn | |
| 705445 | Withdrawn | |
| 706854 | Withdrawn | |
| 706143 | Withdrawn | |
| 705562 | Withdrawn | |
| 700096 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jaeger | Jaeger Medical GmbH | 227 |
| 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 |
| TrueOne 2400 | Parvomedics, Incorporated | 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.