Axess Scavenging Circuit, In-Line 53005

GUDID 00813830026788

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer
Primary Device ID00813830026788
NIH Device Record Keya61113f4-f52f-4526-9252-b252cd1ee027
Commercial Distribution Discontinuation2199-12-14
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxess Scavenging Circuit, In-Line
Version Model Number53005
Catalog Number53005
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
GS100813830026788 [Primary]
GS100813830027914 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-14
Device Publish Date2018-12-14

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