Typenex Heat and Moisture Exchanger with Filter

GUDID 10810050854433

Heat and Moisture Exchanger with Filter (Small)

TYPENEX MEDICAL LLC

Heat/moisture exchanger/microbial medical gas filter
Primary Device ID10810050854433
NIH Device Record Key24871339-693b-4019-a580-8cfa51e5a5e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTypenex Heat and Moisture Exchanger with Filter
Version Model NumberRE0101
Company DUNS600850213
Company NameTYPENEX MEDICAL LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810050854436 [Primary]
GS110810050854433 [Package]
Contains: 00810050854436
Package: Case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-13
Device Publish Date2022-04-05

On-Brand Devices [Typenex Heat and Moisture Exchanger with Filter]

10810050854440Heat and Moisture Exchanger with Filter (Large)
10810050854433Heat and Moisture Exchanger with Filter (Small)

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