BE 142-a

The reusable BE 142-A is designed for use with ventilators, anesthesia machines, resuscitators, and other systems where PEEP or CPAP is required. A threshold-like resistance is applied…

Registry build 21.09.26

The reusable BE 142-A is designed for use with ventilators, anesthesia machines, resuscitators, and other systems where PEEP or CPAP is required. A threshold-like resistance is applied after active exhalation. The PEEP valve prevents the exhalation pressure from dropping below a pre-determined value. PEEP ranges are adjustable from 3 to 20cm of water. Maximum PEEP can vary +/-10%. Objectives of PEEP therapy: 1) increase functional residual capacity by maintaining a positive pressure throughout the ventilatory cycle – improves gas distribution, 2) aid in the prevention of atelectasis via aveolar stinting, 3) decrease in the inspired oxygen fraction (FiO2) is an advantage, 4) help in the stabilization of flail chest condition, and 5) monitor tidal volume by connecting a spirometer to the outlet port.

9manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (5), Fujian (3), elsewhere (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BYE
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
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Ambu Limited Xiang Yu F.T.Z., Xiamen Fujian Contract manufacturer 11
Flying Tooling Engineering Limited Dongguan Guangdong Contract manufacturer 9
Laerdal Medical (Suzhou) Co., Ltd. 215009 Suzhou Jiangsu Province Repacker / relabeller 12
Shenzhen Wellcore Well Technology Co., Ltd. Shenzhen Guangdong Manufacturer 2

Record

Regulatory record for BE 142-A
Listed by Instrumentation Industries, Incorporated, United States
FDA product code BYE
Device type Attachment, Breathing, Positive End Expiratory Pressure
Device class Class 2
Regulation 21 CFR 868.5965
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k) K963347
Record published 2015-10-24
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation High-level Disinfectant, Ethylene Oxide, Radiation Sterilization, Moist Heat or Steam Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for BE 142-A
Catalogue number Size Status
BE 142-A In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
O2-MAX Pulmodyne Inc. 136
02-MAX Pulmodyne Inc. 83
02-RESQ Pulmodyne Inc. 43
Flow-Safe II Disposable CPAP System Mercury Medical Enterprises, LLC 36
Curaplex® Bound Tree Medical, LLC 31
AincA Anesthesia Associates, Inc. 30
Flow-Safe Disposable CPAP System Mercury Medical Enterprises, LLC 29
Attachment, Breathing, Positive End Expiratory Pressure Galemed Corp. 25
Shiley Covidien LP 21
Infant Resuscitation Kit. T-Piece Circuit Flexicare Medical Ltd. 20
AirLife Carefusion 17
O2-RESQ Pulmodyne Inc. 17

Showing 12 of 139. All products under Attachment, Breathing, Positive End Expiratory Pressure

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K963347 1997-03-19

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer