FDA.reportPublic FDA data

ProChamber Assembly

Primary DI
00383730000718
Brand
ProChamber Assembly
Company
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
Model
00
Catalog number
HS2003-050
Device description
PROCHAMBER VHC - 50PK
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWFSPIROMETER, THERAPEUTIC (INCENTIVE)
CAFNebulizer (direct patient interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032809000
K870514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032809000HOSPITAL SPACERRespironics Healthscan, Inc.2003-11-13CAF
K870514000THRESHOLD(TM) INSPIRATORY MUSCLE TRAINERHealth Products, Inc.1987-03-31BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00383730000718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00383730000718003837300007183837300007180383730000718

GMDN Terms#

Term, Definition table
TermDefinition
Medicine chamber spacer, reusableA device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)744-2500respironics.service@philips.com
+1(724)387-4000RESPIRONICS.SERVICE@PHILIPS.COM

Regulatory Flags#

DUNS number
220018415
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00383730000657ProChamber Assembly00HS-0062016-08-24
00383730000664PROCHAMBER Assembly0010401912016-08-24
00383730000671PROCHAMBER Assembly0010691772016-08-24
00383730000688ProChamber Assembly0011174882016-08-24
00383730000695ProChamber Assembly0011174892016-08-24
00383730000701ProChamber Assembly0011174902016-08-24
00383730004013INNOSPIRE ESSENCE112740911274092019-06-27
00383730003993Innospire Essence112954211295422019-06-17
00383730004006INNOSPIRE ESSENCE112953911295392019-06-17
00383730004037Innospire Essence112818211281822019-06-17
00383730004419Innospire Elegance0011368252019-06-10
00383730001050SideStream0010468382016-08-24
00383730001067SideStream0012012016-08-24
00383730001074Sidestream0010594872016-08-24
00383730001081SideStream0010722862016-09-21
00383730001098SideStream001200A2016-08-24
00383730001104Sidestream001223A2016-08-24
00383730001111Sidestream001224A2016-08-24
00383730001210SideStream001225A2016-08-24
00383730001227SideStream00PT12002016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919343Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-10
00607411919367Salter Labs® Full Kit Nebulizer SetSALTER LABSCAF2026-06-10
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
04719882305610MaxiPEPENCHANT TEK. CO, LTD.BWF2026-05-28
00848530107932Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-01-26
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
00789091681588Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-06-03
00848530096137Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-05-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
00848530087524Power and AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087531Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099893Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099923Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087517Nebulizer Medicine CupSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099107Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087500Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093884Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095062Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095079Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530089818Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093853Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530094805Nebulizer KitSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530098216Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100377Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100384Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100391Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100407Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30