MAX-250K

GUDID 00817770020516

Oxygen Sensor Bulk Pack with Viasys DC Connector

MAXTEC, LLC

Respiratory oxygen sensor Respiratory oxygen sensor
Primary Device ID00817770020516
NIH Device Record Keyf6fdbec3-e9ae-4dde-a4c9-a97b1614e670
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAX-250K
Version Model NumberR125P11
Company DUNS169911828
Company NameMAXTEC, LLC
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817770020516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-14
Device Publish Date2016-09-27

On-Brand Devices [MAX-250K]

00817770020516Oxygen Sensor Bulk Pack with Viasys DC Connector
00817770020356Oxygen Sensor with Viasys Panduit Connector

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