Non-Scav. Sys. Tube Size Reducing Kit 35600

GUDID 00813830022438

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer
Primary Device ID00813830022438
NIH Device Record Keye994425e-4272-4c3a-8f08-396512ab2f9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNon-Scav. Sys. Tube Size Reducing Kit
Version Model Number35600
Catalog Number35600
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813830022438 [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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