MaxBlend2 R229P02-010

GUDID 00817770025856

MaxBlend2, High Flow 0-15 LPM DISS 50 PSI

MAXTEC, LLC

Oxygen/air breathing gas mixer, hospital
Primary Device ID00817770025856
NIH Device Record Keybaf3867a-a712-46c9-9f49-924934410127
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaxBlend2
Version Model NumberHigh Flow
Catalog NumberR229P02-010
Company DUNS169911828
Company NameMAXTEC, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS100817770025856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZRMixer, Breathing Gases, Anesthesia Inhalation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-22
Device Publish Date2024-08-14

On-Brand Devices [MaxBlend2]

00817770021520MaxBlend2 0-30 LPM AFNOR 50 PSI
00817770021513MaxBlend2 0-3 LPM NIST 50 PSI
00817770021506MaxBlend2 0-15 LPM AFNOR 50 PSI
00817770021490MaxBlend2 0-15 LPM NIST 50 PSI
00817770021483MaxBlend2 0-30 LPM AFNOR 50 PSI
00817770021391AIR/OXYGEN BLENDER,0-15 lpm, NIST, 60 psi
00817770021384AIR OXYGEN BLENDER, 0-30 lpm, NIST, 50 psi
00817770021261Maxblend2 0-15 LPM Bird with DISS and 60 psi
00853061006388MaxBlend2, Low Flow, Bird w/AFNOR
00853061006371MaxBlend2, High Flow, Bird w/AFNOR
00853061006333MaxBlend2, High Flow, Bird with NIST
00853061006326Low Flow with Diss Fitting (BioMed)
00853061006319High Flow with DISS Fitting (BioMed)
00853061006265MaxBlend2 High Flow Bird Blender DISS
00853061006043MaxBlend2 Low Flow Bird Blender DISS Fitting
00817770025672MaxBlend2 High Flow 0-70 LPM Flowmeter DISS Fitting
00817770025856MaxBlend2, High Flow 0-15 LPM DISS 50 PSI

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.