Who else makes this device?

Name: Resuscitation Unit 104 E type (Stand-alone type)
Brand: Resuscitation Unit 104 E type (Stand-alone type)

Anesthesiology › TherapeuticVentilator, Emergency, Powered (Resuscitator)

Resuscitation Unit 104 E Type (Stand-Alone Type)

Catalogue number 60982, listed by Atom Medical Corporation, Japan, under Ventilator, Emergency, Powered (Resuscitator). 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

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 Resuscitation Unit 104 E type (Stand-alone type)
Listed by	Atom Medical Corporation, Japan
FDA product code	BTL
Device type	Ventilator, Emergency, Powered (Resuscitator)
Device class	Class 2
Regulation	21 CFR 868.5925
Establishment	Contract manufacturer, Manufacturer, Exporter
Record published	2016-09-21
Record revised	2019-07-12 (version 4)

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	Height 370 mm; width 200 mm

Catalogue Numbers

Catalogue numbers for Resuscitation Unit 104 E type (Stand-alone type)
Catalogue number	Size	Status
60982	Height 370 mm	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
K102542	2011-04-06

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.