Inspirachamber with SootherMask (small) and InspiraMask (small)

GUDID 30327437025019

Inspirachamber Anti-static Valved Holding Chamber with SootherMask (small) and InspiraMask (small) (Retail Unit)

LUPIN PHARMACEUTICALS, INC.

Medicine chamber spacer, reusable
Primary Device ID30327437025019
NIH Device Record Key01e86ce1-f721-4413-a78b-59823a1ecd19
Commercial Distribution StatusIn Commercial Distribution
Brand NameInspirachamber with SootherMask (small) and InspiraMask (small)
Version Model NumberIPX1025
Company DUNS089153071
Company NameLUPIN PHARMACEUTICALS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-399-2561
Emailinfo@askarm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100327437025018 [Primary]
GS130327437025019 [Package]
Contains: 00327437025018
Package: Shipper [10 Units]
In Commercial Distribution

FDA Product Code

NVPHolding Chambers, Direct Patient Interface

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-09
Device Publish Date2019-08-31

Devices Manufactured by LUPIN PHARMACEUTICALS, INC.

00327437024011 - InspiraChamber Anti-static Valved Holding Chamber2019-09-09 InspiraChamber Anti-static Valved Holding Chamber (Retail Unit)
30327437025019 - Inspirachamber with SootherMask (small) and InspiraMask (small)2019-09-09Inspirachamber Anti-static Valved Holding Chamber with SootherMask (small) and InspiraMask (small) (Retail Unit)
30327437025019 - Inspirachamber with SootherMask (small) and InspiraMask (small)2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with SootherMask (small) and InspiraMask (small) (Retail Unit)
30327437026016 - Inspirachamber with SootherMask (medium) and InspiraMask (medium)2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with SootherMask (medium) and InspiraMask (medium) (Retail Unit)
30327437043013 - Inspirachamber with Inspiramask (Large)2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with InspiraMask (Large) (Retail Unit)

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