FDA.reportPublic FDA data

RESPICHAMBER* VHC with Mouthpiece

Primary DI
00762860001138
Brand
RESPICHAMBER* VHC with Mouthpiece
Company
Trudell Medical International
Model
101533
Device description
RESPICHAMBER™ VHC with Mouthpiece
Published
2024-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVPHolding Chambers, Direct Patient Interface

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVPHolding Chambers, Direct Patient InterfaceAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110136000RESPICHAMBER VALVED HOLDING CHAMBERTrudell Medical Intl.2011-04-18NVP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10762860001135PackageGS1100In Commercial Distribution
00762860001138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076286000113510762860001135
00762860001138007628600011387628600011380762860001138

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.

Contacts#

Phone, Email table
PhoneEmail
1-519-455-4862customerservice@trudellmed.com

Regulatory Flags#

DUNS number
203298203
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00762860000582OMBRA* Table Top Compressor System 105510105510940062025-11-06
00762860055100OMBRA 120V Table Top Compressor System1055102020-03-25
62860105509026AEROECLIPSE BAN Replacement Mouthpiece Assembly105509105509940802020-03-24
62860105501020AEROECLIPSE II Breath Actuated Nebulizer Disposable105501105501940502016-09-24
62860105505028AEROECLIPSE II Breath Actuated Nebulizer Disposable with Elbow Adapter105505105505940502016-09-24
62860105506025AEROECLIPSE II Elbow Adapter for Breath Actuated Nebulizer Disposable105506105506940502016-09-24
62860105507022AEROECLIPSE XL Reusable Breath Actuated Nebulizer w AeroControl System Regulator105507105507940102016-09-24
62860105513016AeroEclipse* XL Breath Actuated Nebulizer105513105510940062016-09-24
62860105514020EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN105514105514940102016-09-30
62860105541026AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing105541105541940502016-09-24
62860105542023AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing105542105542940502016-09-24
00762860055025REUSABLE COMFORTSEAL® Silicone Mask Assembly1055022024-03-11
00762860055032REUSABLE COMFORTSEAL® Silicone Mask Assembly1055032024-03-11
00762860055049REUSABLE COMFORTSEAL® Silicone Mask Assembly1055042024-03-11
10762860001135RESPICHAMBER* VHC with Mouthpiece1015332024-03-11
10762860055022REUSABLE COMFORTSEAL® Silicone Mask Assembly1055022024-03-11
10762860055039REUSABLE COMFORTSEAL® Silicone Mask Assembly1055032024-03-11
10762860055046REUSABLE COMFORTSEAL® Silicone Mask Assembly1055042024-03-11
00762860000827AEROCHAMBER* MV Holding Chamber825918251100502023-12-01
00762860125018RespiConnect* Adapter112501112501940402020-02-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05023323030054VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-24
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05023323030023VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-07
00383480000594LiteAire BASICTHAYER MEDICAL CORPORATIONNVP2024-09-11
00848530102685Nebulizer KitSUNSET HEALTHCARE SOLUTIONS, INC.NVP2024-08-01
05023323029799InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-29
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05023323029829InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-29
05023323029768InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-24
05023323029782InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-24
05023323029751InspiraChamber®FLEXICARE MEDICAL LIMITEDNVP2024-05-17
05023323029775InspiraChamber® FLEXICARE MEDICAL LIMITEDNVP2024-05-17
10762860001135RESPICHAMBER* VHC with MouthpieceTrudell Medical InternationalNVP2024-03-11
00604351504127Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2024-03-01
50604351504122Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2024-03-01
00604351501126Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00604351502123Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00604351503120Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00604351500129Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
50604351501121Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
50604351502128Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
50604351503125Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00842135100091Antistatic Compact Space Chamber with Medium Antistatic MaskMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDNVP2023-08-07
00842135100107Antistatic Compact Space Chamber with Large Antistatic MaskMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDNVP2023-08-07
10842135100098Antistatic Compact Space Chamber with Medium Antistatic MaskMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDNVP2023-08-07