AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing

GUDID 10762860055411

AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing

Trudell Medical International

Nebulizing system delivery set, reusable
Primary Device ID10762860055411
NIH Device Record Key7e5d16c9-240c-4f63-a59c-d9f74499f631
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing
Version Model Number105541
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
GS100762860055414 [Primary]
GS110762860055411 [Package]
Contains: 00762860055414
Package: [50 Units]
In Commercial Distribution
GS162860105541026 [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 Date2020-02-27
Device Publish Date2020-02-19

On-Brand Devices [AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing]

62860105541026AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing
10762860055411AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing

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