CPR-2 Bag
231 catalogue numbers from 10-56322, listed by Mercury Medical Enterprises, LLC, United States, under Ventilator, Emergency, Manual (Resuscitator). 8 manufacturers in China are registered for this product 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 | Mercury Medical Enterprises, LLC, United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K954866 |
| Record published | 2015-10-31 |
| Record revised | 2019-05-22 (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 |
| Storage | Storage environment temperature -40 to 60 °C |
| Packaging | Pack of 6, pack of 12, pack of 10 |
| Distribution end date | 2019-05-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-56322 | In distribution | |
| 10-58506 | In distribution | |
| 10-56058 | In distribution | |
| 10-56061 | In distribution | |
| 10-56065 | In distribution | |
| 10-56316 | In distribution | |
| 10-56321 | In distribution | |
| 10-56320 | In distribution | |
| 10-56312 | In distribution | |
| 10-56066 | In distribution | |
| 10-56024 | In distribution | |
| 10-56442 | In distribution | |
| 10-56431 | In distribution | |
| 10-56036 | In distribution | |
| 10-56214 | In distribution | |
| 10-56303 | In distribution | |
| 10-56255 | In distribution | |
| 10-56165 | In distribution | |
| 10-56215 | In distribution | |
| 10-56304 | In distribution | |
| 10-56028 | In distribution | |
| 10-56176 | In distribution | |
| 10-56424 | In distribution | |
| 10-56069 | In distribution | |
| 10-56314 | In distribution | |
| 10-56234 | In distribution | |
| 10-56302 | In distribution | |
| 10-56005 | In distribution | |
| 10-56457 | In distribution | |
| 10-56008 | In distribution | |
| 10-56031 | In distribution | |
| 10-56152 | In distribution | |
| 10-56003 | In distribution | |
| 10-56236 | In distribution | |
| 10-56034 | In distribution | |
| 10-56123 | In distribution | |
| 10-56118 | In distribution | |
| 10-56053 | In distribution | |
| 10-56325 | In distribution | |
| 10-56434 | In distribution | |
| 10-56113 | In distribution | |
| 10-56037 | In distribution | |
| 10-56269 | In distribution | |
| 10-56602 | In distribution | |
| 10-56238 | In distribution | |
| 10-56077 | In distribution | |
| 10-56307 | In distribution | |
| 10-56101 | In distribution | |
| 10-56258 | In distribution | |
| 10-56147 | In distribution | |
| 10-56319 | In distribution | |
| 10-56267 | In distribution | |
| 10-56044 | In distribution | |
| 10-58205 | In distribution | |
| 10-56301 | In distribution | |
| 10-56052 | In distribution | |
| 10-56115 | In distribution | |
| 10-56204 | In distribution | |
| 10-56264 | In distribution | |
| 10-58507 | In distribution | |
| 10-56075 | In distribution | |
| 10-56253 | In distribution | |
| 10-56402 | In distribution | |
| 10-56002 | In distribution | |
| 10-56121 | In distribution | |
| 10-56157 | In distribution | |
| 10-56010 | In distribution | |
| 10-56202 | In distribution | |
| 10-56445 | In distribution | |
| 10-56138 | In distribution | |
| 10-56405 | In distribution | |
| 10-56148 | In distribution | |
| 10-58203 | In distribution | |
| 10-56110 | In distribution | |
| 10-56212 | In distribution | |
| 10-56411 | In distribution | |
| 10-56406 | In distribution | |
| 10-56168 | In distribution | |
| 10-56050 | In distribution | |
| 10-56041 | In distribution | |
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| 10-58509 | In distribution | |
| 10-56310 | In distribution | |
| 10-56067 | In distribution | |
| 10-58202 | In distribution | |
| 10-56305 | In distribution | |
| 10-56027 | In distribution | |
| 10-56056 | In distribution | |
| 10-56250 | In distribution | |
| 10-56224 | In distribution | |
| 10-56129 | In distribution | |
| 10-58207 | In distribution | |
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| 10-56221 | In distribution | |
| 10-56095 | In distribution | |
| 10-56142 | In distribution | |
| 10-56601 | In distribution | |
| 10-58501 | In distribution | |
| 10-56151 | In distribution | |
| 10-58600 | In distribution | |
| 10-58512 | In distribution | |
| 10-56116 | In distribution | |
| 10-56459 | In distribution | |
| 10-56055 | In distribution | |
| 10-56213 | In distribution | |
| 10-56460 | In distribution | |
| 10-56120 | In distribution | |
| 10-56308 | In distribution | |
| 10-56436 | In distribution | |
| 10-58603 | In distribution | |
| 10-56076 | In distribution | |
| 10-56254 | In distribution | |
| 10-56201 | In distribution | |
| 10-56119 | In distribution | |
| 10-56009 | In distribution | |
| 10-56114 | In distribution | |
| 10-56084 | In distribution | |
| 10-56262 | In distribution | |
| 10-56266 | In distribution | |
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| 10-56029 | In distribution | |
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| 10-56026 | In distribution | |
| 10-56025 | In distribution | |
| 10-56071 | In distribution | |
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| 10-56111 | In distribution | |
| 10-56051 | In distribution | |
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| 10-56042 | In distribution | |
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| 10-56240 | In distribution | |
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| 10-56455 | In distribution | |
| 10-56222 | In distribution | |
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| 10-56103 | In distribution | |
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| 10-56230 | In distribution | |
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| 10-56049 | In distribution | |
| 10-56232 | In distribution | |
| 10-56137 | In distribution | |
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| 10-56225 | In distribution | |
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| 10-56032 | In distribution | |
| 10-56102 | In distribution | |
| 10-58209 | In distribution | |
| 10-56603 | In distribution | |
| 10-58208 | In distribution | |
| 10-56040 | In distribution | |
| 10-56241 | Withdrawn | |
| 10-56231 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 405 |
| 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 |
| Vital Signs | Carefusion | 31 |
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.