Oxygen Sensor R140P28

GUDID 00817770025788

Max-125W-VME Medical Oxygen Sensor

MAXTEC, LLC

Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor
Primary Device ID00817770025788
NIH Device Record Key938cadfd-bfa4-46c6-8220-af06beb962be
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxygen Sensor
Version Model NumberMax-125W-VME
Catalog NumberR140P28
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 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
GS100817770025788 [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 Date2023-06-16
Device Publish Date2023-06-08

On-Brand Devices [Oxygen Sensor]

00817770022428MAX-125M Medical Oxygen Sensor
00817770025719Max-125W Oxygen Sensor
00817770025788Max-125W-VME Medical Oxygen Sensor
00817770025641Max-550 MaxBlend External Medical Oxygen Sensor Taiwan Labeled

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