Ultra DC Oral Surgery Package C 46200OS

GUDID 00813830023121

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer
Primary Device ID00813830023121
NIH Device Record Key2485858b-ceee-41ba-b464-6d3c729e8af0
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra DC Oral Surgery Package C
Version Model Number46200OS
Catalog Number46200OS
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 Numbertrue
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
GS100813830023121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSZGas-Machine, Anesthesia

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 Date2016-09-24

On-Brand Devices [Ultra DC Oral Surgery Package C]

0081383002312146200OS
0081383002553846200-OS

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