Giraffe Stand-Alone Infant Resuscitation System
Giraffe Stand-Alone Infant Resuscitation System BAG AND Mask
8manufacturers in China registered for this device type
1catalogue number
1recall
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 | Datex-Ohmeda, Inc., United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K070247 |
| Record published | 2015-09-23 |
| Record revised | 2025-04-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -25 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Bag and Mask | 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)
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 |
|---|---|---|---|---|---|---|---|
| Datex-Ohmeda, Inc. | 510(k) number | 2026-05-08 | Class I | Process control | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia | 550 (367 US; 183 OUS) | |
| 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. | 15 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. | 48 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 |
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.