BagEasy
Neonatal/Infant Resuscitator w/Peep and Mask, AMBU Disposable Manometer
8manufacturers in China registered for this device type
24catalogue numbers in this listing
2recalls on this code
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 | Westmed, Inc., United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Contract manufacturer, Remanufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K940581 |
| Record published | 2015-10-24 |
| Record revised | 2023-09-29 (version 5) |
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 12, pack of 6 |
| Distribution end date | 2023-09-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 562236 | In distribution | |
| 562201 | In distribution | |
| 562202 | In distribution | |
| 562111DM | In distribution | |
| 562041 | In distribution | |
| 562133 | Withdrawn | |
| 562048DM | Withdrawn | |
| 562203 | Withdrawn | |
| 562235 | Withdrawn | |
| 562111 | Neonatal/Infant | Withdrawn |
| 562013 | Withdrawn | |
| 562082 | Withdrawn | |
| 562233 | Withdrawn | |
| 562136 | Withdrawn | |
| 562081 | Withdrawn | |
| 562190 | Withdrawn | |
| 562048 | Withdrawn | |
| 562200 | Withdrawn | |
| 562040 | Withdrawn | |
| 562084 | Withdrawn | |
| 562234 | Withdrawn | |
| 562086 | Withdrawn | |
| 562080 | Withdrawn | |
| 562237 | Withdrawn |
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
2 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 |
|---|---|---|---|---|---|---|---|
| Westmed, Inc. | 510(k) number | 2010-06-22 | Not classified | Nonconforming Material/Component | This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device. | 22145 | 2011-03-22 |
| Westmed, Inc. | 510(k) number | 2010-06-22 | Not classified | Nonconforming Material/Component | This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device. | 2,734 | 2011-03-22 |
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.