Resp-O2 Heat Moisture Exchanger & Filter

GUDID 00840117305854

Resp-O2 Heat Moisture Exchanger & Filter (HMEF) 1500 w/ B/V Filter and CO2 Port; Adult

DYNAREX CORPORATION

Heat/moisture exchanger/microbial filter, non-sterile
Primary Device ID00840117305854
NIH Device Record Key066bd923-2135-455f-956b-81059abe51d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Heat Moisture Exchanger & Filter
Version Model Number30102
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117305847 [Primary]
GS100840117305854 [Package]
Contains: 00840117305847
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 Date2021-04-30
Device Publish Date2021-04-22

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