EU Scavenging Circuit I 33010EU

GUDID 00813830021479

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer
Primary Device ID00813830021479
NIH Device Record Key802ea131-2a9b-446b-b89b-4a2ea7b4fc37
Commercial Distribution StatusIn Commercial Distribution
Brand NameEU Scavenging Circuit I
Version Model Number33010EU
Catalog Number33010EU
Company DUNS088302096
Company NameACCUTRON, 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813830021479 [Primary]
GS100813830027860 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBNApparatus, Gas-Scavenging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-06
Device Publish Date2016-09-24

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