Medumat Easy CPR

MEDUMAT Easy CPR is an electrically controlled, pneumatically operated ventilator for emergency care and transport. Qualified medical personnel use it to ventilate adults and children…

Registry build 21.09.26

MEDUMAT Easy CPR is an electrically controlled, pneumatically operated ventilator for emergency care and transport. Qualified medical personnel use it to ventilate adults and children weighing over 10 kg whose spontaneous breathing is absent or inadequate, using a mask or tube.

Compressed medical oxygen passes through an external pressure reducer before entering the ventilator. A control knob sets linked breathing frequency and tidal-volume parameters. Gas travels through the ventilation hose and patient valve to the patient, while a membrane in the valve permits exhalation.

Monitoring and Transport

The ventilator continuously measures airway pressure and provides visual and audible alarms. Its intended settings include mobile emergency deployments, land or air transport, and transfers between hospital rooms or departments.

4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (3), Fujian (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BTL
Manufacturer City Province Registered as Device types
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Dongguan Plastiflex Hose Technology Ltd Dongguan Guangdong Contract manufacturer 3

Record

Regulatory record for Medumat Easy CPR
Listed by Weinmann Emergency Medical Technology Gmbh, Germany
FDA product code BTL
Device type Ventilator, Emergency, Powered (Resuscitator)
Device class Class 2
Regulation 21 CFR 868.5925
Establishment Manufacturer
510(k) K193191
Record published 2020-12-09

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Medumat Easy CPR
Catalogue number Size Status
20315 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Life Support Products Allied Medical LLC 50
Neo-Tee T-Piece Resuscitator Mercury Medical Enterprises, LLC 45
Pneupac ICU Medical, Inc 38
Allied Medical LLC Allied Medical LLC 19
Fisher & Paykel Healthcare Fisher & Paykel Healthcare, Ltd. 18
AincA Anesthesia Associates, Inc. 17
Neo-Tee T-Piece Resuscitator Circuit Mercury Medical Enterprises, LLC 12
Life Support Products (LSP) Allied Medical LLC 12
Moves Thornhill Research Inc. 11
Ventlab Ventlab, LLC 7
Resusa-Tee T-Piece Resuscitator Mercury Medical Enterprises, LLC 7
Curaplex Bound Tree Medical, LLC 5

Showing 12 of 70. All products under Ventilator, Emergency, Powered (Resuscitator)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K193191 2020-11-20

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