FLOCAP, MEDLINE 24 PK

GUDID 20817770020817

MAXTEC, LLC

Exhaled-gas oesophageal intubation detector, adult
Primary Device ID20817770020817
NIH Device Record Key120fdfda-e5f0-4501-8197-5dee5efe3670
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLOCAP, MEDLINE 24 PK
Version Model NumberR500P21-001
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS120817770020817 [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 Number4
Public Version Date2019-12-23
Device Publish Date2016-09-27

Devices Manufactured by MAXTEC, LLC

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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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