MaxCap Reg

GUDID 00817770021674

MAXTEC, LLC

Exhaled-gas oesophageal intubation detector, adult
Primary Device ID00817770021674
NIH Device Record Key0dc7ebac-6948-4bad-a3f6-51fe31d4a151
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaxCap Reg
Version Model NumberR500P30
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS100817770021674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-23
Device Publish Date2018-07-12

Devices Manufactured by MAXTEC, LLC

00817770025665 - Oxygen Sensor2024-08-22 Sensor, Max-250E Oxygen Taiwan
00817770025849 - Analyzer2024-08-22 Analyzer, MaxO2+ A with 60 PSI BlenderBuddy
00817770025856 - MaxBlend22024-08-22 MaxBlend2, High Flow 0-15 LPM DISS 50 PSI
00817770025863 - Manifold2024-08-22 Manifold, Acrylic 0-70 White Nist 660 PSI
00817770025870 - Manifold2024-08-22 Manifold, Acrylic 0-70 White DISS 60 PSI F&P
00817770025931 - Analyzer2024-08-22 Analyzer, MaxO2+A with Low Flow 15 LPM BlenderBuddy2
00817770025948 - Analyzer2024-08-22 Analyzer, MaxO2+ Inspirational Healthcare
00817770025955 - Manifold2024-08-22 Manifold, Acrylic 0-70 Dual Qhite Aust 60 PSI F&P

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