Pressure Monitoring Line with Nafion Dryer (BioMed Private Label)

GUDID 00817770026068

Pressure Monitoring Line with Nafion Dryer (BioMed Private Label) - SINGLE, EACHES LEVEL

MAXTEC, LLC

Gas-sampling/monitoring respiratory tubing, single-use
Primary Device ID00817770026068
NIH Device Record Keyd5e1650b-e419-498f-a858-8f08b9907dbc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePressure Monitoring Line with Nafion Dryer (BioMed Private Label)
Version Model NumberR229P18-001
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 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
GS100817770026068 [Primary]

FDA Product Code

CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-29
Device Publish Date2025-07-21

Devices Manufactured by MAXTEC, LLC

00817770026068 - Pressure Monitoring Line with Nafion Dryer (BioMed Private Label)2025-07-29Pressure Monitoring Line with Nafion Dryer (BioMed Private Label) - SINGLE, EACHES LEVEL
00817770026068 - Pressure Monitoring Line with Nafion Dryer (BioMed Private Label)2025-07-29 Pressure Monitoring Line with Nafion Dryer (BioMed Private Label) - SINGLE, EACHES LEVEL
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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

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