CLEAR-THERM MICRO HMEF L/PORT

GUDID 05030267038312

CLEAR-THERM MICRO HMEF L/PORT

INTERSURGICAL INCORPORATED

Heat/moisture exchanger/microbial filter, non-sterile
Primary Device ID05030267038312
NIH Device Record Key70966b34-6e6e-4c0d-8864-8f909a55456c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLEAR-THERM MICRO HMEF L/PORT
Version Model Number1441000
Company DUNS785952607
Company NameINTERSURGICAL INCORPORATED
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105030267038305 [Package]
Package: [80 Units]
In Commercial Distribution
GS105030267038312 [Package]
Contains: 05030267052523
Package: [20 Units]
In Commercial Distribution
GS105030267052523 [Primary]

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 Date2021-10-12
Device Publish Date2021-10-04

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