Gas Filter Unit ACC-GFU-100

GUDID 10894338002693

Gas Filter Unit, Box of 10

OMNIGUIDE, INC.

Microbial medical gas filter, non-sterile, single-use
Primary Device ID10894338002693
NIH Device Record Key678ad991-8ed6-406b-b5a6-ac9bbb631c26
Commercial Distribution StatusIn Commercial Distribution
Brand NameGas Filter Unit
Version Model NumberACC-GFU-100
Catalog NumberACC-GFU-100
Company DUNS030124221
Company NameOMNIGUIDE, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100894338002733 [Package]
Package: Box [10 Units]
In Commercial Distribution
GS110894338002693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

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10894338002693 - Gas Filter Unit2018-07-06Gas Filter Unit, Box of 10
10894338002693 - Gas Filter Unit2018-07-06 Gas Filter Unit, Box of 10

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