Who else makes this device?

Name: PulmoSal 7% (pH+)
Brand: PulmoSal 7% (pH+)

Anesthesiology › TherapeuticNebulizer (Direct Patient Interface)

PulmoSal 7% (Ph+)

PulmoSal 7% (pH+) is a sodium chloride inhalation solution used with a nebulizer to induce sputum production. It is intended for patients who require sputum induction in home, hospital or…

Registry build 21.09.26

PulmoSal 7% (pH+) is a sodium chloride inhalation solution used with a nebulizer to induce sputum production. It is intended for patients who require sputum induction in home, hospital or subacute care settings under prescription.

The nebulizer turns the saline solution into an aerosol for inhalation. This version contains sodium chloride at a concentration of 7% and has a pH of 7.4. The solution is a clear, colorless mixture of sodium chloride and sterile water.

Listed Item

Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyrogenic

Vial Presentation

The solution is supplied sterile and preservative-free in 4mL blow-fill-sealed low-density polyethylene vials. The listed carton contains 60 vials.

42manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

1recall

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 PulmoSal 7% (pH+)
Listed by	Pharmacaribe LLC, United States
FDA product code	CAF
Device type	Nebulizer (Direct Patient Interface)
Device class	Class 2
Regulation	21 CFR 868.5630
Establishment	Specification developer, Manufacturer
510(k)	K130091
Record published	2016-10-07
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 50 to 86 °F
Packaging	Case of 12
Sizes	Total volume 4 ml

Catalogue Numbers

Catalogue numbers for PulmoSal 7% (pH+)
Catalogue number	Size	Per pack	Status
74060	Total Volume 4 ml	60	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
K130091	2013-03-13
K101424	2010-08-17

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 PulmoSal 7% (pH+)
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Pharmacaribe LLC	510(k) number	2015-12-29	Class II	Error in labeling	Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)	7,020 vials	2017-03-28

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.