AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing 10554294050

GUDID 62860105542023

AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing

Trudell Medical International

Nebulizing system, non-heated Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated
Primary Device ID62860105542023
NIH Device Record Keye1e61e05-973d-4cc1-8eb7-10181cdc5b44
Commercial Distribution Discontinuation2020-01-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing
Version Model Number105542
Catalog Number10554294050
Company DUNS203298203
Company NameTrudell Medical International
Device Count50
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-519-455-4862
Emailcustomerservice@trudellmed.com
Phone1-519-455-4862
Emailcustomerservice@trudellmed.com
Phone1-519-455-4862
Emailcustomerservice@trudellmed.com
Phone1-519-455-4862
Emailcustomerservice@trudellmed.com
Phone1-519-455-4862
Emailcustomerservice@trudellmed.com
Phone1-519-455-4862
Emailcustomerservice@trudellmed.com
Phone1-519-455-4862
Emailcustomerservice@trudellmed.com
Phone1-519-455-4862
Emailcustomerservice@trudellmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS162860105542016 [Unit of Use]
GS162860105542023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-06
Device Publish Date2016-09-24

On-Brand Devices [AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing]

62860105542023AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing
10762860055428AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing

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