PEU Scavenging Ciruit II 32007PEU

GUDID 00813830021349

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer
Primary Device ID00813830021349
NIH Device Record Keyf1eff96d-79e8-4b2d-8a89-b61f61396cb0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEU Scavenging Ciruit II
Version Model Number32007PEU
Catalog Number32007PEU
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
GS100813830021349 [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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