Neo-Tee T-Piece Resuscitator
45 catalogue numbers from 10-50821, listed by Mercury Medical Enterprises, LLC, United States, under Ventilator, Emergency, Powered (Resuscitator). 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
45catalogue numbers in this listing
3recalls on this code
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 | Mercury Medical Enterprises, 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, Repacker / relabeller, Manufacturer |
| 510(k) | K093913 |
| Record published | 2015-09-24 |
| Record revised | 2021-07-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
| Distribution end date | 2021-07-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-50821 | In distribution | |
| 10-50809 | In distribution | |
| 10-50839 | In distribution | |
| 10-50802 | In distribution | |
| 10-50823 | In distribution | |
| 10-50811 | In distribution | |
| 10-50838 | In distribution | |
| 10-50807 | In distribution | |
| 10-50810 | In distribution | |
| 10-50841 | In distribution | |
| 10-50806 | In distribution | |
| 10-50823 | In distribution | |
| 10-50803 | In distribution | |
| 10-50829 | In distribution | |
| 10-50808 | In distribution | |
| 10-50822 | In distribution | |
| 10-50825 | In distribution | |
| 10-50805 | In distribution | |
| 10-50842 | In distribution | |
| 10-50815 | In distribution | |
| 10-50840 | In distribution | |
| 10-50837 | In distribution | |
| 10-50831 | In distribution | |
| 10-50832 | In distribution | |
| 10-50843 | In distribution | |
| 10-50814 | In distribution | |
| 10-50804 | Withdrawn | |
| 10-50826 | Withdrawn | |
| 10-50816 | Withdrawn | |
| 10-50819 | Withdrawn | |
| 10-50800 | Withdrawn | |
| 10-50833 | Withdrawn | |
| 10-50820 | Withdrawn | |
| 10-50824 | Withdrawn | |
| 10-50818 | Withdrawn | |
| 10-50834 | Withdrawn | |
| 10-50830 | Withdrawn | |
| 10-50812 | Withdrawn | |
| 10-50801 | Withdrawn | |
| 10-50828 | Withdrawn | |
| 10-50817 | Withdrawn | |
| 10-50836 | Withdrawn | |
| 10-50827 | Withdrawn | |
| 10-50813 | Withdrawn | |
| 10-50835 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Life Support Products | Allied Medical LLC | 50 |
| 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)
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Mercury Medical Enterprises, LLC | 510(k) number | 2024-12-10 | Class I | Process change control | Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pr | 37370 | |
| Mercury Medical Enterprises, LLC | 510(k) number | 2024-08-30 | Class I | Process control | Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. | 1,300 units | |
| Mercury Medical Enterprises, LLC | 510(k) number | 2015-10-22 | Class II | Device Design | Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient. | 753,245 devices | 2017-10-13 |
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.