What is FDA product code NVP?

Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles

Anesthesiology › TherapeuticHolding Chambers, Direct Patient Interface

Inspirachamber With SootherMask (Small) and InspiraMask (Small)

Name: Inspirachamber with SootherMask (Small) and InspiraMask (Small)
Brand: Inspirachamber with SootherMask (Small) and InspiraMask (Small)

InspiraChamber Anti-Static Valved Holding Chamber with SootherMask and InspiraMask- Hospital Unit

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NVP
Manufacturer	City	Province	Registered as	Device types
Flexicare Medical (Dongguan) Ltd.	Dongguan	Guangdong	Contract manufacturer	48
Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Koo (Shanghai) Industries Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	9

Record

Regulatory record for Inspirachamber with SootherMask (Small) and InspiraMask (Small)
Listed by	Inspirx, Inc., United States
FDA product code	NVP
Device type	Holding Chambers, Direct Patient Interface
Device class	Class 2
Regulation	21 CFR 868.5630
Record published	2017-12-01
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, manufacturing date
Packaging	Pack of 10

Catalogue Numbers

Catalogue numbers for Inspirachamber with SootherMask (Small) and InspiraMask (Small)
Catalogue number	Size	Status
IC-SMS-0		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aerochamber Plus® Flow-Vu®	Monaghan Medical Corp.	23
OptiChamber Diamond	Respironics Respiratory Drug Delivery (Uk), Ltd.	8
InspiraChamber Valved Holding Chamber	Inspirx, Inc.	8
Aerochamber Plus® Z Stat®	Monaghan Medical Corp.	5
Monaghan™ Z Stat®	Monaghan Medical Corp.	5
InspiraChamber®	Clement Clarke Intl., Ltd.	5
VentiChamber	Clement Clarke Intl., Ltd.	5
Clever Choice	Simple Diagnostics	3
Flexichamber	Avadel Pharmaceuticals (USA), Inc.	2
Breathe Comfort	Slv Pharmaceuticals LLC	2
Flexichamber	Cerecor Inc.	2
InspiraChamber®	Flexicare Medical Ltd.	2

Showing 12 of 38. All products under Holding Chambers, Direct Patient Interface

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K130598	2013-06-05

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.