Life Support Products
Ventilator, Mass Casualty, w/BL, German, Pneumatic and Electric
4manufacturers in China registered for this device type
50catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Fujian (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 |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Dongguan Plastiflex Hose Technology Ltd | Dongguan | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Allied Medical LLC, United States |
|---|---|
| FDA product code | BTL |
| Device type | Ventilator, Emergency, Powered (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5925 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K915564 |
| Record published | 2015-11-20 |
| Record revised | 2025-10-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L063R | In distribution | |
| MCV200-ES | In distribution | |
| L063-03R | In distribution | |
| L760 | In distribution | |
| L560 | In distribution | |
| L034-101R | In distribution | |
| L576 | In distribution | |
| L762 | In distribution | |
| L034-100R | In distribution | |
| MCV100-B | In distribution | |
| L763 | In distribution | |
| L762CPAP | In distribution | |
| L034-101R-JM | In distribution | |
| L760CPAP | In distribution | |
| MCV100-B-ES | In distribution | |
| MCV200-B-PL | In distribution | |
| MCV200-DE | In distribution | |
| MCV200-PL | In distribution | |
| L063-050FE | In distribution | |
| L763CPAP | In distribution | |
| L324-030 | In distribution | |
| MCV200 | In distribution | |
| L034-100I | In distribution | |
| L063-03TF | In distribution | |
| MCV200-B-ES | In distribution | |
| L231-050 | In distribution | |
| MCV200-B | In distribution | |
| MCV200-B-DE | In distribution | |
| L034-102R | In distribution | |
| L569 | In distribution | |
| L576-010 | In distribution | |
| L576-020 | In distribution | |
| L544 | In distribution | |
| L034-102 | In distribution | |
| L761CPAP | In distribution | |
| L324-030I | In distribution | |
| L576-040 | In distribution | |
| L465 | In distribution | |
| MCV-AUXBAT | In distribution | |
| L324-050 | In distribution | |
| MCV100-ES | In distribution | |
| L063-050FO | In distribution | |
| L761 | In distribution | |
| L461-150 | In distribution | |
| L063-030 | In distribution | |
| MCV100 | In distribution | |
| L576-030 | In distribution | |
| L034-100K | In distribution | |
| L063-050 | In distribution | |
| L324-513 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neo-Tee T-Piece Resuscitator | Mercury Medical Enterprises, LLC | 45 |
| Pneupac | ICU Medical, Inc | 38 |
| Allied Medical LLC | Allied Medical LLC | 19 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 18 |
| AincA | Anesthesia Associates, Inc. | 17 |
| Neo-Tee T-Piece Resuscitator Circuit | Mercury Medical Enterprises, LLC | 12 |
| Life Support Products (LSP) | Allied Medical LLC | 12 |
| Moves | Thornhill Research Inc. | 11 |
| Ventlab | Ventlab, LLC | 7 |
| Resusa-Tee T-Piece Resuscitator | Mercury Medical Enterprises, LLC | 7 |
| Curaplex | Bound Tree Medical, LLC | 5 |
| Macs | Airon Corporation | 4 |
Showing 12 of 70. All products under Ventilator, Emergency, Powered (Resuscitator)
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.