Charcoal Output Filter ICM-000-0421

GUDID 00817688021704

I.C. MEDICAL, INC.

Surgical plume evacuation system
Primary Device ID00817688021704
NIH Device Record Key3f93eb7d-0292-4757-9edb-99e9f30b6071
Commercial Distribution StatusIn Commercial Distribution
Brand NameCharcoal Output Filter
Version Model Number2220
Catalog NumberICM-000-0421
Company DUNS616182895
Company NameI.C. MEDICAL, INC.
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 Datetrue
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
GS100817688021704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYDApparatus, Exhaust, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-08
Device Publish Date2016-09-24

On-Brand Devices [Charcoal Output Filter]

008176880217042220
00817688021698ICM-000-0025

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