MAX-250T Internal

GUDID 00085306100647

Oxygen Sensor

MAXTEC, LLC

Respiratory oxygen sensor
Primary Device ID00085306100647
NIH Device Record Key40f49f5e-67b8-4f17-8394-63463f3f9bdf
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAX-250T Internal
Version Model NumberR125P18-011
Company DUNS169911828
Company NameMAXTEC, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does n
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
GS100085306100647 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by MAXTEC, LLC

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00817770020974 - Flowmeter2023-06-20 0-70 LMP Oxygen Flowmeter NPT Female Fitting 60 PSI White Knob
00817770025818 - EyeMax22023-06-20 EyeMax2 Micro 20/Pack Italian (Italian Label)
00817770025825 - EyeMax22023-06-20 EyeMax2 Preemie Italian 20/Pack (Italian Label)
00817770025832 - EyeMax22023-06-20 EyeMax2 Regular 20/Pack (Italian Label)
00817770022213 - SmartStack2023-06-16 SmartStack Bundle
00817770022220 - SmartStack2023-06-16 SmartStack Bundle with Dual Tank Holder

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