Home GUDID 30327437043013 Inspirachamber with Inspiramask (Large)
Primary DI 30327437043013
Brand Inspirachamber with Inspiramask (Large)
Company LUPIN PHARMACEUTICALS, INC.
Model IPX1043
Device description Inspirachamber Anti-static Valved Holding Chamber with InspiraMask (Large) (Retail Unit)
Published 2019-08-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name NVP Holding Chambers, Direct Patient Interface
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NVP Holding Chambers, Direct Patient Interface Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30327437043013 Package GS1 10 In Commercial Distribution 00327437043012 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30327437043013 30327437043013 00327437043012 00327437043012 327437043012 0327437043012
GMDN Terms# Term, Definition table Term Definition Medicine chamber spacer, reusable A 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 089153071 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00327437025018 Inspirachamber with SootherMask (small) and InspiraMask (small) IPX1025 2019-08-31 00327437026015 Inspirachamber with SootherMask (medium) and InspiraMask (medium) IPX1026 2019-08-30 00327437043012 Inspirachamber with Inspiramask (Large) IPX1043 2019-08-30 00327437024011 InspiraChamber Anti-static Valved Holding Chamber IPX1024 2019-08-30 30327437025019 Inspirachamber with SootherMask (small) and InspiraMask (small) IPX1025 2019-08-31 30327437026016 Inspirachamber with SootherMask (medium) and InspiraMask (medium) IPX1026 2019-08-30
Other Devices Sharing Product Codes# 
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