Easy Grip
This Bag Valve Mask Resuscitator kit contains an Adult EASY GRIP® PVC Bag Valve Mask Resuscitator, three different sizes Guedel Airways and two different sizes Face masks for adult…
This Bag Valve Mask Resuscitator kit contains an Adult EASY GRIP® PVC Bag Valve Mask Resuscitator, three different sizes Guedel Airways and two different sizes Face masks for adult patients. The Adult EASY GRIP® PVC Bag Valve Mask Resuscitator is a reusable device for manual ventilation. It is designed for use in various clinical settings to provide respiratory support to the respiratory distressed or non-breathing ADULT patient. When used with a supplemental oxygen supply, the device may provide 100% oxygen on every squeeze of the bag. The Resuscitator comes with a Pressure Relief Valve set at 70 cm H2O, which can be overridden by the operator if desired.
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 | O-TWO Medical Technologies, Inc., Canada |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2015-10-26 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature -40 to 60 °C |
| Packaging | Corrugated carton of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01BM3600 | In distribution | |
| 01BM2000-M | In distribution | |
| 01BM3700-M | In distribution | |
| 01BM3520 | In distribution | |
| 01BM3610 | In distribution | |
| 01BM3710 | In distribution | |
| 01BM3500 | In distribution | |
| 01BM3510 | In distribution | |
| 01BM3700 | In distribution | |
| 01BM3511 | In distribution | |
| 01BM3620 | In distribution | |
| 01BM3720 | In distribution | |
| 01BM3501 | 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.