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.

Registry build 21.09.26
8manufacturers in China registered for this device type
231catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code BTM
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

Regulatory record for CPR-2 Bag
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

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 numbers for CPR-2 Bag
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
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10-56445 In distribution
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10-56067 In distribution
10-58202 In distribution
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10-58603 In distribution
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10-58201 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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer