Giraffe Stand-Alone Infant Resuscitation System
Giraffe Stand-Alone Infant Resuscitation System T-Piece
4manufacturers in China registered for this device type
1catalogue number
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 | Datex-Ohmeda, Inc., United States |
|---|---|
| FDA product code | BTL |
| Device type | Ventilator, Emergency, Powered (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5925 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K070210 |
| Record published | 2015-09-23 |
| Record revised | 2025-04-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 0 to 95 % RH; Storage environment temperature -25 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T-piece | In distribution |
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 |
| 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 |
Showing 12 of 70. All products under Ventilator, Emergency, Powered (Resuscitator)
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| GE Healthcare GmbH | 510(k) number | 2013-12-12 | Class II | Process control | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. | 375 units | 2015-06-01 |
| GE Healthcare GmbH | 510(k) number | 2013-12-12 | Class II | Process control | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. | 561 units | 2015-06-01 |
| GE Medical Systems, LLC | 510(k) number | 2013-10-01 | Class I | Component design/selection | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. | 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown | 2016-07-22 |
| GE Medical Systems, LLC | 510(k) number | 2012-10-15 | Class I | Employee error | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. | 276 units total, 109 of those nationwide. | 2017-01-18 |
| GE Medical Systems, LLC | 510(k) number | 2012-06-26 | Class I | Nonconforming Material/Component | Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure. | 209,804 circuits | 2014-04-14 |
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.