Life Support Products
Infant, Disp, Resus, w / Pop Off - Neonate Mask / Tubing
8manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Fujian (4), Zhejiang (1), Guangdong (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Xiamen Compower Medical Tech. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
Record
| Listed by | Allied Medical LLC, United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K921553 |
| Record published | 2015-11-23 |
| Record revised | 2025-10-13 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 6, case of 16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L238-212 | In distribution | |
| L670-040 | In distribution | |
| DS201 | In distribution | |
| L670-202 | In distribution | |
| L770-040 | In distribution | |
| L670-111 | In distribution | |
| L670-220 | In distribution | |
| L670-101 | In distribution | |
| L770-101 | In distribution | |
| DS202 | In distribution | |
| L670-050 | In distribution | |
| L554-270 | In distribution | |
| L238-220 | In distribution | |
| L670-100 | In distribution | |
| L554-005 | In distribution | |
| DS203 | In distribution | |
| L554-300 | In distribution | |
| L770-100 | In distribution | |
| L238-210 | In distribution | |
| L670-200 | In distribution | |
| L238-222 | In distribution | |
| L670-060 | In distribution | |
| L670-210 | In distribution | |
| L670-222 | In distribution | |
| L544-000 | In distribution | |
| L670-110 | In distribution | |
| L770-200 | In distribution | |
| L670-120 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 405 |
| CPR-2 Bag | Mercury Medical Enterprises, LLC | 231 |
| CPR Bag | Mercury Medical Enterprises, LLC | 187 |
| Vital Signs™ | Airlife, Inc. | 102 |
| Medline | Medline Industries, Inc. | 78 |
| Spur® II Pediatric ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 74 |
| Spur® II Adult ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 66 |
| Hudson RCI | Teleflex Medical LLC | 56 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53 |
| Portex | ICU Medical, Inc | 45 |
| Spur® II Infant ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 45 |
| Curaplex® | Bound Tree Medical, LLC | 38 |
Showing 12 of 342. All products under Ventilator, Emergency, Manual (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.