Who else makes this device?

Name: Manual Jet Ventilator
Brand: Manual Jet Ventilator

Anesthesiology › TherapeuticVentilator, Emergency, Powered (Resuscitator)

Manual Jet Ventilator

The BE 183-SUR-12 Manual Jet Ventilator is designed to provide trans-tracheal ventilation in specific emergency situations of upper airway obstructions. This system is used in conjunction…

Registry build 21.09.26

The BE 183-SUR-12 Manual Jet Ventilator is designed to provide trans-tracheal ventilation in specific emergency situations of upper airway obstructions. This system is used in conjunction with a trans-tracheal catheter, or cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by the manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.

4manufacturers in China registered for this device type

4catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

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 Manual Jet Ventilator
Listed by	Instrumentation Industries, Incorporated, United States
FDA product code	BTL
Device type	Ventilator, Emergency, Powered (Resuscitator)
Device class	Class 2
Regulation	21 CFR 868.5925
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k)	K991785
Record published	2015-10-19
Record revised	2018-07-06 (version 3)

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 Manual Jet Ventilator
Catalogue number	Size	Status
BE 183-SUR		In distribution
BE 183-SUR-12		In distribution
BE 183-SU		In distribution
BE 183-SU-12		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
K991785	1999-08-17
K860077	1986-02-18

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Manual Jet Ventilator
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Instrumentation Industries, Incorporated	510(k) number	2012-09-07	Class II	Error in labeling	Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.	2998	2013-07-05

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.