Who else makes this device?

Name: Salter Labs® Full Kit Nebulizer Set
Brand: Salter Labs® Full Kit Nebulizer Set

Salter Labs® Full Kit Nebulizer Set · Nebulizer (Direct Patient Interface) → Anesthesiology

42manufacturers in China registered for this device type

1catalogue number

9510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (23), Jiangsu (7), Fujian (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAF
Manufacturer	City	Province	Registered as	Device types
Flexicare Medical (Dongguan) Ltd.	Dongguan	Guangdong	Contract manufacturer	48
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
Hangzhou Jinlin Medical Appliances Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	11
Shenzhen Huayan E-Commerce Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	11
Shenzhen BI-Rich Medical Devices Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	9
Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Omron (Dalian) Co., Ltd. (Plant 1)	Dalian	Liaoning	Contract manufacturer	7
Apex Medical (Kunshan) Corp.	Kunshan	Jiangsu	Contract manufacturer	4
Dongguan Polygreen Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	4
Living Science Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	3

Showing 12 of 42. All 42 manufacturers in China registered for Nebulizer (Direct Patient Interface)

Record

Regulatory record for Salter Labs® Full Kit Nebulizer Set
Listed by	Salter Labs, United States
FDA product code	CAF
Device type	Nebulizer (Direct Patient Interface)
Device class	Class 2
Regulation	21 CFR 868.5630
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K961476
Record published	2026-06-10

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Packaging	Pack of 50

Catalogue Numbers

Catalogue numbers for Salter Labs® Full Kit Nebulizer Set
Catalogue number	Size	Status
13952		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Hudson RCI	Teleflex Medical LLC	220
AirLife	Carefusion	77
AirLife™	Airlife, Inc.	76
Ventlab	Ventlab, LLC	56
I-neb	Respironics Respiratory Drug Delivery (Uk), Ltd.	55
Aerogen® Solo Nebulizer System	Aerogen Ltd	53
Portex	ICU Medical, Inc	50
Sidestream	Respironics Respiratory Drug Delivery (Uk), Ltd.	48
Hudson RCI	Medline Industries, Inc.	46
DeVilbiss	DeVilbiss Healthcare LLC.	45
Drive	Drive DeVilbiss Healthcare	42
Drivemedical	Drive DeVilbiss Healthcare	40

Showing 12 of 541. All products under Nebulizer (Direct Patient Interface)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K014056	2002-02-01
K992285	2000-01-07
K992986	1999-09-24
K991788	1999-08-06
K983403	1998-12-17
K962879	1996-10-22
K962085	1996-08-26
K961476	1996-07-16
K884947	1989-02-17

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 Salter Labs® Full Kit Nebulizer Set
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
SunMed Group Holdings, LLC	510(k) number	2015-08-04	Class II	Component change control	The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.	8,975	2016-05-06

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.

Salter Labs® Full Kit Nebulizer Set