Axess Mask, Small Mint, 24 Pk 53037-16

GUDID 00813830026757

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer
Primary Device ID00813830026757
NIH Device Record Key6f4489f2-4330-4889-9478-bb7e2a237a10
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxess Mask, Small Mint, 24 Pk
Version Model Number53037-16
Catalog Number53037-16
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 Usetrue
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
GS100813830026757 [Primary]

FDA Product Code

KHAMask, Scavenging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-03-08

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