Who else makes this device?

Name: Wall Mount Bracket for Instant Flow Valves
Brand: Wall Mount Bracket for Instant Flow Valves

Anesthesiology › TherapeuticVentilator, Emergency, Manual (Resuscitator)

Wall Mount Bracket for Instant Flow Valves

Bracket attaches to the wall, and to rail-mounted versions of Instant Flow Valves for On/Off control of oxygen flow when using a resuscitator bag: For use with hyperinflation bag (not…

Registry build 21.09.26

Bracket attaches to the wall, and to rail-mounted versions of Instant Flow Valves for On/Off control of oxygen flow when using a resuscitator bag: For use with hyperinflation bag (not included) weighing 3 ounces to 4 pounds (90-1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing the bag on the arm of the valve. Immediate oxygen flow is provided when bag is lifted from the arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.

8manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

2recalls on this code

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 Wall Mount Bracket for Instant Flow Valves
Listed by	Instrumentation Industries, Incorporated, United States
FDA product code	BTM
Device type	Ventilator, Emergency, Manual (Resuscitator)
Device class	Class 2
Regulation	21 CFR 868.5915
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k)	K970959
Record published	2015-10-01
Record revised	2019-11-04 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Wall Mount Bracket for Instant Flow Valves
Catalogue number	Size	Status
BE 3000-WM		In distribution

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
CPR Bag	Mercury Medical Enterprises, LLC	187
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

Showing 12 of 342. All products under Ventilator, Emergency, Manual (Resuscitator)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K970959	1997-06-13
K831486	1983-08-12
K823408	1982-12-07

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2003-09-12	Not classified	Other	possible external debris in the on/off plunger.	46 units	2004-02-26
2003-09-12	Not classified	Other	possible external debris in the on/off plunger.	46 units	2004-02-26

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.