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Data / Medical devices / Holding Chambers, Direct Patient Interface

Holding Chambers, Direct Patient Interface (NVP): 14 FDA-registered makers in 8 countries

14 establishments in 8 countries are registered with the FDA to make Holding Chambers, Direct Patient Interface (product code NVP, Class 2, 21 CFR 868.5630). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on January 15, 2025, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
NVP
Device class
2
Regulation
868.5630
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States5
China3
Canada1
Brazil1
United Kingdom1
Australia1
India1
Taiwan1

Makers of Holding Chambers, Direct Patient Interface

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Monaghan Medical Corp.Plattsburgh, NY, United StatesContract manufacturer, Manufacturer4January 15, 2025000api.fda.gov
Trudell Medical InternationalLONDON Ontario, CanadaManufacturer, Specification developer4January 15, 2025000api.fda.gov
Thayer Medical CorportationTucson, AZ, United StatesManufacturer2April 1, 2022000api.fda.gov
Agaplastic Ind. Com. Ltda.Rio De Janeiro, BrazilComplaint file establishment, Foreign private label distributor, Manufacturer1April 29, 2011000api.fda.gov
Clement Clarke Intl., Ltd.Mountain Ash Rhondda Cynon Taff, United KingdomSpecification developer1June 5, 2013000api.fda.gov
Koo (Shanghai) Industries Co., LtdSongjiang Shanghai, ChinaManufacturer1January 28, 2011000api.fda.gov
Medical Developments InternationalScoresby Victoria, AustraliaManufacturer1January 26, 2016000api.fda.gov
Philips Global Business Services LLPBaner Pune Maharashtra, IndiaManufacturer, Specification developer1August 9, 2011000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Specification developer1August 9, 2011000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesManufacturer1June 5, 2013000api.fda.gov
Flexicare Medical (dongguan) Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Foremount Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer0000api.fda.gov
Nolato GW TucsonTucson, AZ, United StatesContract manufacturer0000api.fda.gov
Respironics Medical Products (Shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov

Updated January 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.