Who else makes this device?

Name: Midas, REM, 50%-W-O2, Eavs
Brand: Midas, REM, 50%-W-O2, Eavs

Midas, REM, 50%-W-O2, Eavs · Mixer, Breathing Gases, Anesthesia Inhalation → Anesthesiology

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code BZR
Manufacturer	City	Province	Registered as	Device types
Sunmed AP, Ltd.	Zhuhai	Guangdong	Contract manufacturer	18
Gentec (Shanghai) Corporation	Shanghai	Shanghai	Manufacturer	12

Record

Regulatory record for Midas, REM, 50%-W-O2, Eavs
Listed by	Parker Hannifin Corp., United States
FDA product code	BZR
Device type	Mixer, Breathing Gases, Anesthesia Inhalation
Device class	Class 2
Regulation	21 CFR 868.5330
510(k)	K241465
Record published	2024-10-14

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date

Catalogue Numbers

Catalogue numbers for Midas, REM, 50%-W-O2, Eavs
Catalogue number	Size	Status
6130-EAVS		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sechrist Industries, Inc.	Sechrist Industries, Inc.	43
Hyperinflation	Westmed, Inc.	21
Blender	Carefusion	19
Hyperinflation (Ambu)	Westmed, Inc.	19
MAXBLEND2	Maxtec, LLC	17
Blender	Vyaire Medical, Inc.	17
Ambu Hyperinflation System	Westmed, Inc.	12
Ambu	SunMed Group Holdings, LLC	12
MaxFlo2	Maxtec, LLC	11
MicroMax	Maxtec, LLC	9
Bird™	Vyaire Medical, Inc.	8
Gentec®	Gentec (Shanghai) Corporation	8

Showing 12 of 118. All products under Mixer, Breathing Gases, Anesthesia Inhalation

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K241465	2024-09-19
K202480	2021-04-22

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.

Midas, REM, 50%-W-O2, Eavs