MC 300* Nebulizer with Universal Tubing

GUDID 10762860055541

MC 300* Nebulizer with Universal Tubing

Trudell Medical International

Nebulizing system delivery set, reusable
Primary Device ID10762860055541
NIH Device Record Key7c96f198-d2f3-4981-9f0b-18cbbce0f4f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMC 300* Nebulizer with Universal Tubing
Version Model Number105554
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
GS100762860055544 [Primary]
GS110762860055541 [Package]
Contains: 00762860055544
Package: [50 Units]
In Commercial Distribution

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

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