MAX02+

GUDID 00817770020684

ANALYZER, MAX02+ MEDICAL AE INTERNATIONAL

MAXTEC, LLC

Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered
Primary Device ID00817770020684
NIH Device Record Keyff582e05-a9f5-4c3c-8c02-f6aea739b5d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAX02+
Version Model NumberR217P72-003
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 Batchtrue
Serial Numbertrue
Manufacturing Datefalse
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
GS100817770020684 [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 Date2019-01-14
Device Publish Date2018-03-27

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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