Large Multi Use Non Scavenger Cir 33011-A

GUDID 00813830021493

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer
Primary Device ID00813830021493
NIH Device Record Key0988335f-80fa-4e34-9b0d-e43ddeaa6a4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLarge Multi Use Non Scavenger Cir
Version Model Number33011-A
Catalog Number33011-A
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
GS100813830021493 [Primary]

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-28

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