Inspirachamber with SootherMask (small) and InspiraMask (small)

Primary DI
30327437025019
Brand
Inspirachamber with SootherMask (small) and InspiraMask (small)
Company
LUPIN PHARMACEUTICALS, INC.
Model
IPX1025
Device description
Inspirachamber Anti-static Valved Holding Chamber with SootherMask (small) and InspiraMask (small) (Retail Unit)
Published
2019-08-31
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30327437025019PackageGS110In Commercial Distribution
00327437025018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3032743702501930327437025019
00327437025018003274370250183274370250180327437025018

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
1-800-399-2561info@askarm.com

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 DIBrandModelCatalogPublished
00327437025018Inspirachamber with SootherMask (small) and InspiraMask (small)IPX10252019-08-31
00327437026015Inspirachamber with SootherMask (medium) and InspiraMask (medium)IPX10262019-08-30
00327437043012Inspirachamber with Inspiramask (Large)IPX10432019-08-30
00327437024011InspiraChamber Anti-static Valved Holding ChamberIPX10242019-08-30
30327437026016Inspirachamber with SootherMask (medium) and InspiraMask (medium)IPX10262019-08-30
30327437043013Inspirachamber with Inspiramask (Large)IPX10432019-08-30

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