MAX-250TEL

GUDID 00853061006630

Oxygen Sensor

MAXTEC, LLC

Respiratory oxygen sensor
Primary Device ID00853061006630
NIH Device Record Key1b97b119-e014-44bb-9275-4acd22a77396
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAX-250TEL
Version Model NumberR125P18-010
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
GS100853061006630 [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

10817770021121 - SmartStack2023-10-18 IV Pole 8 Pack
00817770020561 - EyeMax22023-06-20 EyeMax2 Kit (Contains a 20/pack each of Regular, Preemie, and Micro)
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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