Astral
Single Limb Valve Adapter
1manufacturer
12catalogue numbers in this listing
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 |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
Record
| Listed by | Resmed PTY Ltd., Australia |
|---|---|
| FDA product code | NOU |
| Device type | Continuous, Ventilator, Home Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2015-12-07 |
| Record revised | 2026-05-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -4 to 122 °F; Storage environment humidity 5 to 93 % RH |
| Distribution end date | 2023-07-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 27937 | 40 | In distribution | |
| 27941 | In distribution | ||
| 100 | In distribution | ||
| 27936 | In distribution | ||
| 27919 | In distribution | ||
| 27942 | In distribution | ||
| 19620 | In distribution | ||
| 19948 | In distribution | ||
| 27917 | In distribution | ||
| 150 | In distribution | ||
| 27940 | In distribution | ||
| 27943 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vivo 50 | Breas Medical, Inc. | 17 |
| Patient Circuit | Flight Medical Innovations Ltd. | 13 |
| Trilogy Evo | Respironics Inc. | 10 |
| Trilogy | Respironics Inc. | 10 |
| Care Orchestrator | Respironics Inc. | 10 |
| Trilogy 200 | Respironics Inc. | 5 |
| Continuous Ventilator | Flight Medical Innovations Ltd. | 3 |
| Trilogy 100 | Respironics Inc. | 3 |
| Vocsn Roll Stand | Ventec Life Systems, Inc. | 2 |
| Sensor | Respironics Inc. | 2 |
| Astral Double Limb Kit | Resmed PTY Ltd. | 1 |
| Trilogy EV300 | Respironics Inc. | 1 |
Showing 12 of 28. All products under Continuous, Ventilator, Home Use
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Resmed PTY Ltd. | UDI-DI | 2026-06-25 | Class I | Component design/selection | Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy. | 168,069 devices globally |
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.