MaxFlo2 R223P01

GUDID 00853061006005

Oxygen/air breathing gas mixer, hospital

Primary Device ID	00853061006005
NIH Device Record Key	db6961d9-db38-4b3f-ab89-10a16ebbc6cb
Commercial Distribution Discontinuation	2019-05-06
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	MaxFlo2
Version Model Number	Low Flow DISS
Catalog Number	R223P01
Company DUNS	169911828
Company Name	MAXTEC, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Temperature	Between -10 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00853061006005 [Primary]

BZR	Mixer, Breathing Gases, Anesthesia Inhalation

Steralize Prior To Use	false
Device Is Sterile	false

00817770020806	MaxFlo2 Mini 0-70 LPM
00817770020790	High Flow System
00817770020783	Low Flow System
00853061006159	High Flow Spanish Labeled
00853061006142	High Flow with MaxO2+ Nist Fitting Kit
00853061006135	Low Flow with MaxO2+ DISS Fitting Kit
00853061006067	High Flow with MaxO2+, DISS Fitting Kit
00853061006050	Low low with MaxO2+A, DISS Fitting Kit
00853061006036	High Flow with NIST Fitting
00853061006029	MaxFlo2 High Flow with DISS Fitting
00853061006005	MaxFlo2 Low Flow DISS Fitting