ULPA Filter & Water Trap

GUDID 00817688021469

I.C. MEDICAL, INC.

Surgical plume evacuation system
Primary Device ID00817688021469
NIH Device Record Key6d11e017-4396-410d-bbe7-c4d6a4c9e12f
Commercial Distribution StatusIn Commercial Distribution
Brand NameULPA Filter & Water Trap
Version Model NumberICM-000-0307
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
GS100817688021452 [Primary]
GS100817688021469 [Package]
Contains: 00817688021452
Package: [25 Units]
In Commercial Distribution

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 [ULPA Filter & Water Trap]

008176880214832210
00817688021469ICM-000-0307
00817688021445ICM-000-0014

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