Jaeger
Elbow 45°, ID 30 mm, ULTEM, especially resistant against disinfection
1manufacturer
227catalogue 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) | K181524 |
| Record published | 2025-07-17 |
| Record revised | 2025-09-24 (version 9) |
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, expiry date, 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 | Per pack | Status |
|---|---|---|---|
| V-707723 | In distribution | ||
| V-859141-13 | In distribution | ||
| V-707332 | In distribution | ||
| 720274 | In distribution | ||
| V-176420 | In distribution | ||
| 375119-13 | In distribution | ||
| V-707380 | In distribution | ||
| V-375610 | In distribution | ||
| V-175420-13 | In distribution | ||
| 3.30 | In distribution | ||
| V-172506-13 | In distribution | ||
| V-892650 | In distribution | ||
| V-178600-13 | In distribution | ||
| 172502 | In distribution | ||
| 375119 | In distribution | ||
| V-577084-13 | In distribution | ||
| V-707717 | In distribution | ||
| V-707277 | In distribution | ||
| V-171470-13 | In distribution | ||
| V-375610-13 | In distribution | ||
| 176400 | In distribution | ||
| V-707721 | In distribution | ||
| V-861732 | In distribution | ||
| V-707708 | In distribution | ||
| 375111 | In distribution | ||
| V-178602 | In distribution | ||
| 706696 | In distribution | ||
| V-707377 | In distribution | ||
| V-841234 | In distribution | ||
| V-835490 | In distribution | ||
| 982094 | In distribution | ||
| 852353 | In distribution | ||
| V-707307 | In distribution | ||
| V-178601 | In distribution | ||
| 706132 | In distribution | ||
| V-707746 | 50 | In distribution | |
| V-861078 | In distribution | ||
| V-376406 | In distribution | ||
| 706135 | In distribution | ||
| V-172521 | In distribution | ||
| V-859215 | In distribution | ||
| V-171480-13 | In distribution | ||
| V-707744 | In distribution | ||
| 852360 | In distribution | ||
| V-175423-13 | In distribution | ||
| 706133 | In distribution | ||
| V-375675 | In distribution | ||
| v-852556 | In distribution | ||
| 706265 | In distribution | ||
| 707146 | In distribution | ||
| 706143 | In distribution | ||
| 175400 | In distribution | ||
| V-577400-13 | In distribution | ||
| V-175420 | In distribution | ||
| V-171410 | In distribution | ||
| V-707725 | In distribution | ||
| V-171460 | In distribution | ||
| V-378540 | In distribution | ||
| V-707381 | In distribution | ||
| V-172506 | In distribution | ||
| 707225 | In distribution | ||
| 706188 | In distribution | ||
| V-375650 | In distribution | ||
| 705048 | In distribution | ||
| V-176420-13 | In distribution | ||
| V-176420-13 | In distribution | ||
| 706169 | In distribution | ||
| 171400 | In distribution | ||
| V-707722 | In distribution | ||
| 705388 | In distribution | ||
| 707226 | In distribution | ||
| V-707343 | In distribution | ||
| 706943 | In distribution | ||
| V-171480 | In distribution | ||
| 706134 | In distribution | ||
| 172520 | In distribution | ||
| 709705N | In distribution | ||
| 705445 | In distribution | ||
| 852828 | In distribution | ||
| V-707280 | In distribution | ||
| V-707525 | In distribution | ||
| 711007 | In distribution | ||
| V-707716 | In distribution | ||
| V-375119-03 | In distribution | ||
| V-178500-13 | In distribution | ||
| 706823 | In distribution | ||
| 173115 | In distribution | ||
| V-707340 | In distribution | ||
| V-171470-13 | In distribution | ||
| V-171420 | In distribution | ||
| V-859143 | In distribution | ||
| V-178500 | In distribution | ||
| V-707327 | In distribution | ||
| 706696 | In distribution | ||
| 705562 | In distribution | ||
| V-707525 | In distribution | ||
| 707238 | In distribution | ||
| V-707390 | In distribution | ||
| 706175N | In distribution | ||
| 706854 | In distribution | ||
| V-707274 | In distribution | ||
| V-859140-13 | In distribution | ||
| 705417 | In distribution | ||
| V-707290 | In distribution | ||
| V-172401 | In distribution | ||
| V-175423 | In distribution | ||
| V-171470 | In distribution | ||
| V-175425-13 | In distribution | ||
| 173101 | In distribution | ||
| 375119-13 | In distribution | ||
| V-707326 | In distribution | ||
| 173100 | In distribution | ||
| V-375170 | In distribution | ||
| V-707325 | In distribution | ||
| 705675 | In distribution | ||
| V-173103 | In distribution | ||
| v-178001-13 | In distribution | ||
| 176450-13 | In distribution | ||
| 706188 | In distribution | ||
| 982082 | In distribution | ||
| 143250 | In distribution | ||
| 707230 | In distribution | ||
| 706169 | Withdrawn | ||
| 852353 | Withdrawn | ||
| 175400 | Withdrawn | ||
| 705048 | Withdrawn | ||
| 705417 | Withdrawn | ||
| 706188 | Withdrawn | ||
| V-171470 | Withdrawn | ||
| 173100 | Withdrawn | ||
| 171400 | Withdrawn | ||
| V-175423-13 | Withdrawn | ||
| 982082 | Withdrawn | ||
| V-172506-13 | Withdrawn | ||
| 173116 | Withdrawn | ||
| V-708052 | Withdrawn | ||
| V-577084-13 | Withdrawn | ||
| 2.15 | Withdrawn | ||
| V-375119-03 | Withdrawn | ||
| V-707307 | Withdrawn | ||
| 706134 | Withdrawn | ||
| V-175425-13 | Withdrawn | ||
| 172520 | Withdrawn | ||
| V-171480-13 | Withdrawn | ||
| 705388 | Withdrawn | ||
| V-172506-13 | Withdrawn | ||
| 375111 | Withdrawn | ||
| 172520 | Withdrawn | ||
| V-707277 | Withdrawn | ||
| 705675 | Withdrawn | ||
| 706943 | Withdrawn | ||
| V-172521 | Withdrawn | ||
| 173115 | Withdrawn | ||
| V-708052 | Withdrawn | ||
| 176400 | Withdrawn | ||
| V-707280 | Withdrawn | ||
| 2.13 | Withdrawn | ||
| 706696 | Withdrawn | ||
| 172502 | Withdrawn | ||
| 143250 | Withdrawn | ||
| V-861732 | Withdrawn | ||
| 852360 | Withdrawn | ||
| V-171470-13 | Withdrawn | ||
| V-892650 | Withdrawn | ||
| V-707311-13 | Withdrawn | ||
| V-172506 | Withdrawn | ||
| V-176420-13 | Withdrawn | ||
| 711007 | Withdrawn | ||
| V-171480 | Withdrawn | ||
| V-171460 | Withdrawn | ||
| 709705N | Withdrawn | ||
| 706132 | Withdrawn | ||
| 173115 | Withdrawn | ||
| 172502 | Withdrawn | ||
| 982094 | Withdrawn | ||
| V-175420-13 | Withdrawn | ||
| V-176420-03 | Withdrawn | ||
| V-172401 | Withdrawn | ||
| V-852556 | Withdrawn | ||
| 705562 | Withdrawn | ||
| V-176400-03 | Withdrawn | ||
| 706854 | Withdrawn | ||
| 143250 | Withdrawn | ||
| V-175423-13 | Withdrawn | ||
| V-175425-13 | Withdrawn | ||
| V-178001-13 | Withdrawn | ||
| 706143 | Withdrawn | ||
| 707231 | Withdrawn | ||
| 707226 | Withdrawn | ||
| V-707340 | Withdrawn | ||
| 2.19 | Withdrawn | ||
| V-175420 | Withdrawn | ||
| V-707290 | Withdrawn | ||
| V-707288 | Withdrawn | ||
| V-175420-13 | Withdrawn | ||
| V-176420 | Withdrawn | ||
| V-375111-03 | Withdrawn | ||
| 720274 | Withdrawn | ||
| V-176400-03 | Withdrawn | ||
| V-707311 | Withdrawn | ||
| 173100 | Withdrawn | ||
| V-375170 | Withdrawn | ||
| 705445 | Withdrawn | ||
| V-172506 | Withdrawn | ||
| V-171420 | Withdrawn | ||
| 706135 | Withdrawn | ||
| V-172401 | Withdrawn | ||
| 173101 | Withdrawn | ||
| 176400 | Withdrawn | ||
| V-707280 | Withdrawn | ||
| V-707274 | Withdrawn | ||
| 2.17 | Withdrawn | ||
| 176450-13 | Withdrawn | ||
| 375119-13 | Withdrawn | ||
| 706175N | Withdrawn | ||
| 175400 | Withdrawn | ||
| V-175423 | Withdrawn | ||
| V-173103 | Withdrawn | ||
| 706133 | Withdrawn | ||
| V-146402-03 | Withdrawn | ||
| V-171410 | Withdrawn | ||
| 173101 | Withdrawn | ||
| V-176420-03 | Withdrawn | ||
| V-707274 | Withdrawn | ||
| V-175423 | Withdrawn | ||
| V-175420 | Withdrawn | ||
| V-707340 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.