BlenderBuddy2

GUDID 00817770021711

Low Flow 30 LPM with MaxO2+ A Analyzer

MAXTEC, LLC

Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered
Primary Device ID00817770021711
NIH Device Record Key55c99300-6cd9-477d-b792-0144d16f29d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlenderBuddy2
Version Model NumberR233P04-003
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 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
GS100817770021711 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-25
Device Publish Date2019-01-24

On-Brand Devices [BlenderBuddy2]

00817770021735High Flow 70 LPM with MaxO2+ A Analyzer
00817770021728Low Flow 15 LPM with MaxO2+ A Analyzer
00817770021711Low Flow 30 LPM with MaxO2+ A Analyzer
00817770021704Low Flow 3 LPM with MaxO2+ A Analyzer
00817770021667High Flow 70 LPM
00817770021650Low Flow 30 LPM
00817770021643Low Flow 15 LPM
00817770021636Low Flow 3 LPM

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