Anesthesiology › TherapeuticVentilator, Emergency, Manual (Resuscitator)

CPR Bag

187 catalogue numbers from 10-54103, 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
187catalogue 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 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) K911622
Record published 2018-05-31
Record revised 2020-05-28 (version 6)

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
Packaging Pack of 6, pack of 12
Distribution end date 2021-08-23

Catalogue Numbers

Catalogue numbers for CPR Bag
Catalogue number Size Status
10-54103 In distribution
10-55292 In distribution
10-55188 In distribution
10-55175 In distribution
10-54205 In distribution
10-55071 In distribution
10-55700 In distribution
10-55186 In distribution
10-55115 In distribution
10-55192 In distribution
10-55930 In distribution
10-55196 In distribution
10-55241 In distribution
10-55027 In distribution
10-55002 In distribution
10-55045 In distribution
10-55707 In distribution
10-55288 In distribution
10-54208 In distribution
10-55179 In distribution
10-55713 In distribution
10-58001 In distribution
10-55714 In distribution
10-54100 In distribution
10-54204 In distribution
10-55717 In distribution
10-34501 In distribution
10-55202 In distribution
10-55069 In distribution
10-54210 In distribution
10-55702 In distribution
10-54206 In distribution
10-55070 In distribution
10-54211 In distribution
10-55203 In distribution
10-55298 In distribution
10-55910 In distribution
10-55163 In distribution
10-58002 In distribution
10-55923 In distribution
10-55708 In distribution
10-55156 In distribution
10-55928 In distribution
10-55193 In distribution
10-56447 In distribution
10-55705 In distribution
10-55180 In distribution
10-55073 In distribution
10-55007 In distribution
10-55023 In distribution
10-55078 In distribution
10-55291 In distribution
10-54207 In distribution
10-55173 In distribution
10-54212 In distribution
10-55182 In distribution
10-55072 In distribution
10-55067 In distribution
10-55284 In distribution
10-55217 In distribution
10-55184 In distribution
10-55122 In distribution
10-55701 In distribution
10-55904 In distribution
10-55294 In distribution
10-55283 In distribution
10-55025 In distribution
10-55065 In distribution
10-55918 In distribution
10-55711 In distribution
10-55218 In distribution
10-55295 In distribution
10-55204 In distribution
10-55229 In distribution
10-55155 In distribution
10-55712 In distribution
10-54217 In distribution
10-55108 In distribution
10-54108 In distribution
10-55008 In distribution
10-55189 In distribution
10-55922 In distribution
10-55048 In distribution
10-55903 In distribution
10-54213 In distribution
10-55104 In distribution
10-55715 In distribution
10-55718 In distribution
10-55176 In distribution
10-55183 In distribution
10-55234 In distribution
10-55703 In distribution
10-54203 In distribution
10-55028 In distribution
10-55166 In distribution
10-55000 In distribution
10-56414 In distribution
10-55282 In distribution
10-55250 In distribution
10-58401 In distribution
10-55167 In distribution
10-54201 In distribution
10-55142 In distribution
10-55500 In distribution
10-55141 In distribution
10-55931 In distribution
10-55150 In distribution
10-55119 In distribution
10-54214 In distribution
10-55917 In distribution
10-55704 In distribution
10-55177 In distribution
10-55080 In distribution
10-55912 In distribution
10-55066 In distribution
10-55172 In distribution
10-55003 In distribution
10-55170 In distribution
10-55280 In distribution
10-55916 In distribution
10-55004 In distribution
10-55171 In distribution
10-55082 In distribution
10-55924 In distribution
10-55107 In distribution
10-54111 In distribution
10-55190 In distribution
10-55907 In distribution
10-58400 In distribution
10-55253 In distribution
10-55249 In distribution
10-55168 In distribution
10-55074 In distribution
10-55113 In distribution
10-54221 In distribution
10-55068 In distribution
10-55195 In distribution
10-55293 In distribution
10-55287 In distribution
10-54202 In distribution
10-55297 In distribution
10-55915 In distribution
10-58003 In distribution
10-55102 In distribution
10-56446 In distribution
10-58700 In distribution
10-54209 In distribution
10-54215 In distribution
10-55266 In distribution
10-55279 In distribution
10-55191 In distribution
10-55223 In distribution
10-55264 In distribution
10-55024 In distribution
10-55083 In distribution
10-55079 In distribution
10-55709 In distribution
10-55187 In distribution
10-55081 In distribution
10-55909 In distribution
10-55199 In distribution
10-54218 In distribution
10-55289 In distribution
10-55271 In distribution
10-55061 In distribution
10-54102 In distribution
10-55296 In distribution
10-55224 In distribution
10-55185 In distribution
10-54112 In distribution
10-55103 In distribution
10-55901 In distribution
10-55290 In distribution
10-54200 In distribution
10-55719 In distribution
10-55034 In distribution
10-55299 In distribution
10-55716 In distribution
10-55076 In distribution
10-55064 In distribution
10-54220 In distribution
10-55059 In distribution
10-55106 In distribution
10-58000 In distribution
10-55913 In distribution
10-55200 Withdrawn
10-54216 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ventlab Ventlab, LLC 405
CPR-2 Bag Mercury Medical Enterprises, LLC 231
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