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

Antistatic Compact Space Chamber With Medium Antistatic Mask

Name: Antistatic Compact Space Chamber with Medium Antistatic Mask
Brand: Antistatic Compact Space Chamber with Medium Antistatic Mask

Catalogue number SP-ANTI-SMUSMDI, listed by Medical Developments International, Australia, under Holding Chambers, Direct Patient Interface. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

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 Antistatic Compact Space Chamber with Medium Antistatic Mask
Listed by	Medical Developments International, Australia
FDA product code	NVP
Device type	Holding Chambers, Direct Patient Interface
Device class	Class 2
Regulation	21 CFR 868.5630
Establishment	Manufacturer
Record published	2023-08-07

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number
Storage	Storage environment temperature 41 to 104 °F; Storage environment humidity 15 to 95 % RH; Handling environment temperature 41 to 104 °F; Handling environment humidity 15 to 95 % RH
Packaging	Outer carton of 24

Catalogue Numbers

Catalogue numbers for Antistatic Compact Space Chamber with Medium Antistatic Mask
Catalogue number	Size	Status
SP-ANTI-SMUSMDI		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
K143615	2016-01-26
K122252	2013-11-13

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.