Who else makes this device?

Name: Blender Unit P type
Brand: Blender Unit P type

Anesthesiology › TherapeuticMixer, Breathing Gases, Anesthesia Inhalation

Blender Unit P Type

Catalogue number 60991, listed by Atom Medical Corporation, Japan, under Mixer, Breathing Gases, Anesthesia Inhalation. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Blender Unit P type
Listed by	Atom Medical Corporation, Japan
FDA product code	BZR
Device type	Mixer, Breathing Gases, Anesthesia Inhalation
Device class	Class 2
Regulation	21 CFR 868.5330
Establishment	Contract manufacturer, Manufacturer, Exporter
Record published	2015-09-08
Record revised	2019-01-29 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Handling environment temperature 18 to 40 °C
Sizes	Width 200 mm; height 370 mm

Catalogue Numbers

Catalogue numbers for Blender Unit P type
Catalogue number	Size	Status
60991	Width 200 mm	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
K103317	2011-04-20

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.