Fisher & Paykel Healthcare
S/USE RESUS KIT W 42MM MSK(10)Single use T-Piece-Classic with mask 42mm
4manufacturers in China registered for this device type
18catalogue 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 | Fisher & Paykel Healthcare, Ltd., New Zealand |
|---|---|
| FDA product code | BTL |
| Device type | Ventilator, Emergency, Powered (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5925 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K892885 |
| Record published | 2015-09-25 |
| Record revised | 2026-04-07 (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 |
| Storage | Storage environment temperature -10 to 50 °C |
| Packaging | Pack of 10 |
| Distribution end date | 2026-04-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RD1361-10 | In distribution | |
| RD1340-10 | In distribution | |
| 900RD014-10 | In distribution | |
| RD1301-10 | In distribution | |
| RD1331-10 | In distribution | |
| 900RD015-10 | In distribution | |
| RD1330-10 | In distribution | |
| RD1351-10 | In distribution | |
| 900RD010 | In distribution | |
| 900RD110 | In distribution | |
| RD1360-10 | In distribution | |
| RD1300-10 | In distribution | |
| RD1341-10 | In distribution | |
| RD1350-10 | In distribution | |
| RD1371-10 | In distribution | |
| RD1370-10 | In distribution | |
| 900RD016-10 | In distribution | |
| RD020-01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Life Support Products | Allied Medical LLC | 50 |
| Neo-Tee T-Piece Resuscitator | Mercury Medical Enterprises, LLC | 45 |
| Pneupac | ICU Medical, Inc | 38 |
| Allied Medical LLC | Allied Medical LLC | 19 |
| 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.