AEROECLIPSE II Elbow Adapter for Breath Actuated Nebulizer Disposable

GUDID 10762860055060

Elbow Adapter for AEROECLIPSE II Breath Actuated Nebulizer Disposable

Trudell Medical International

Nebulizing system delivery set, reusable
Primary Device ID10762860055060
NIH Device Record Key6b904ff4-fb2d-4fa7-8bd9-aff3b0684784
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEROECLIPSE II Elbow Adapter for Breath Actuated Nebulizer Disposable
Version Model Number105506
Company DUNS203298203
Company NameTrudell Medical International
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100762860055063 [Primary]
GS110762860055060 [Package]
Contains: 00762860055063
Package: [50 Units]
In Commercial Distribution
GS162860105506025 [Previous]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-26
Device Publish Date2020-02-18

On-Brand Devices [AEROECLIPSE II Elbow Adapter for Breath Actuated Nebulizer Disposable]

62860105506025Elbow Adapter for AEROECLIPSE II Breath Actuated Nebulizer Disposable
10762860055060Elbow Adapter for AEROECLIPSE II Breath Actuated Nebulizer Disposable

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