Inspirachamber with SootherMask (Small) and InspiraMask (Small)

GUDID 00852367007020

InspiraChamber Anti-Static Valved Holding Chamber with SootherMask and InspiraMask- Hospital Unit

INSPIRX, INC

Medicine chamber spacer, reusable
Primary Device ID00852367007020
NIH Device Record Key27f7b604-4c57-4016-bbc7-89c228a71137
Commercial Distribution StatusIn Commercial Distribution
Brand NameInspirachamber with SootherMask (Small) and InspiraMask (Small)
Version Model NumberIC-SMS-0
Company DUNS967174850
Company NameINSPIRX, 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100852367007020 [Primary]
GS110852367007027 [Package]
Package: [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-12-01

Devices Manufactured by INSPIRX, INC

10852367007072 - InspiraChamber Valved Holding Chamber2019-12-19 InspiraChamber with SootherMask (Small) (Teleflex Medical) 1001-10SS
10852367007126 - InspiraChamber Valved Holding Chamber2019-12-19 InspiraChamber with InspiraMask (Large) (Teleflex Medical) 1001-10L
10852367007133 - InspiraChamber Valved Holding Chamber2019-12-19 InspiraChamber with SootherMask (Medium) (Teleflex Medical) 1001-10SM
10852367007157 - InspiraChamber Valved Holding Chamber2019-12-19 InspiraChamber with InspiraMask (Medium) (Teleflex Medical) 1001-10M
10852367007164 - InspiraChamber Valved Holding Chamber2019-12-19 InspiraChamber with InspiraMask (Small) (Teleflex Medical) 1001-10S
10852367007058 - InspiraChamber Valved Holding Chamber2019-07-24 InspiraChamber Anti-Static Valved Holding Chamber (Teleflex Medical) 1001-10
10852367007065 - InspiraChamber Valved Holding Chamber2019-07-24 InspiraChamber Anti-Static Valved Holding Chamber (Teleflex medical) 1001-50
10852367007003 - InspiraChamber Valved Holding Chamber2018-03-29 InspiraChamber Anti-Static Valved Holding Chamber- Hospital Unit

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