Who else makes this device?

Name: WaterPAP Starter Kit
Brand: WaterPAP Starter Kit

Anesthesiology › TherapeuticAttachment, Breathing, Positive End Expiratory Pressure

WaterPAP Starter Kit

WaterPAP Starter Kit consists of 4 WaterPAP canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole clamp, Instructions for use

Registry build 21.09.26

9manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

1recall

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 WaterPAP Starter Kit
Listed by	Airways Development, LLC, United States
FDA product code	BYE
Device type	Attachment, Breathing, Positive End Expiratory Pressure
Device class	Class 2
Regulation	21 CFR 868.5965
Record published	2016-10-03
Record revised	2018-11-05 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for WaterPAP Starter Kit
Catalogue number	Size	Status
WP-7705		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
K110713	2011-09-12

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 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
2015-09-24	Class II	Nonconforming Material/Component	Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determined if this was an isolated incident or if the whole lot is impacted.	1,464 units	2016-05-09

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.