FDA.reportPublic FDA data

InspiraChamber Valved Holding Chamber

Primary DI
00852367007006
Brand
InspiraChamber Valved Holding Chamber
Company
INSPIRX, INC
Model
IC-VHC-0
Device description
InspiraChamber Anti-Static Valved Holding Chamber- Hospital Unit
Published
2017-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NVPHolding Chambers, Direct Patient Interface

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852367007003PackageGS150In Commercial Distribution
00852367007006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085236700700310852367007003
00852367007006008523670070068523670070060852367007006

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.

Regulatory Flags#

DUNS number
967174850
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852367007075InspiraChamber Valved Holding Chamber1001-10SS2019-12-11
00852367007129InspiraChamber Valved Holding Chamber1001-10L2019-12-11
00852367007136InspiraChamber Valved Holding Chamber1001-10SM2019-12-11
00852367007150InspiraChamber Valved Holding Chamber1001-10M2019-12-11
00852367007167InspiraChamber Valved Holding Chamber1001-10S2019-12-11
10852367007072InspiraChamber Valved Holding Chamber1001-10SS2019-12-11
10852367007126InspiraChamber Valved Holding Chamber1001-10L2019-12-11
10852367007133InspiraChamber Valved Holding Chamber1001-10SM2019-12-11
10852367007157InspiraChamber Valved Holding Chamber1001-10M2019-12-11
10852367007164InspiraChamber Valved Holding Chamber1001-10S2019-12-11
00852367007051InspiraChamber Valved Holding Chamber1001-102019-07-16
00852367007068InspiraChamber Valved Holding Chamber1001-502019-07-16
10852367007058InspiraChamber Valved Holding Chamber1001-102019-07-16
10852367007065InspiraChamber Valved Holding Chamber1001-502019-07-16
10852367007003InspiraChamber Valved Holding ChamberIC-VHC-02017-12-18
00852367007013Inspirachamber with InspiraMask (Large)IC-IML-02017-12-18
00852367007020Inspirachamber with SootherMask (Small) and InspiraMask (Small)IC-SMS-02017-12-01
00852367007037Inspirachamber with SootherMask (Medium) and InspiraMask (Medium)IC-SMM-02017-12-01

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Primary DI, Brand, Company table
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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
00762860001138RESPICHAMBER* VHC with MouthpieceTrudell Medical InternationalNVP2024-03-11
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
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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