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Pulmodyne O2-MAX System - HSA Registration DE0504444

Access comprehensive regulatory information for Pulmodyne O2-MAX System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504444 and owned by Pulmodyne, Inc.. The device was registered on May 06, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0504444
Pulmodyne O2-MAX System
HSA Registration Number: DE0504444
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Product Description

O2 Max are medical devices intended to provide CPAP to spontaneously breathing patients in the hospital & pre-hospital (EMS) environment and reduce the work of breathing for the patient

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0504444
Registration Date
May 06, 2020
Retention Due Date
May 05, 2026
Product Owner
Short Name
Pulmodyne, Inc.
Address
2055 Executive Dr, Indianapolis, IN 46241, Indiana, UNITED STATES
Registrant
Address
31 KAKI BUKIT ROAD 3, TECHLINK, #05-12, SINGAPORE 417818
Importer
Address
31 KAKI BUKIT ROAD 3, TECHLINK, #05-12, SINGAPORE 417818
Model Information
Model Name(s)
O2-MAX Fixed System BiTrac ED Mask -Adult LG, 10.0cm O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Med, 10.0cm O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Med, 3 Set O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Med, 5 Set O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 5 Set O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Med, 10.0cm O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 5 Set O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 5 Set O2-CPAP valve, American Gas Connector O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 7.5 Set O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 10.cm Set O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 10.0cm O2-CPAP valve, American Gas Connector O2-MAX Fixed System, BiTrac ED Mask -Adult Med, 5.0cm O2-CPAP valve, American Gas Connector O2-MAX Fixed System, BiTrac ED Mask -Adult Med, 5.0cm O2-CPAP valve O2-MAX Fixed System, BiTrac ED Mask -Adult Med, 7.5cm O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Med, 10.cm O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Med, 10.cm O2-CPAP valve, Ohmeda Connector O2-MAX Fixed System w/Nebulizer, BiTrac ED Mask, Adult Med, 10.0cm O2 CPAP Valve O2-MAX Fixed System w/Nebulizer, BiTrac ED Mask, Adult Med, 10.0cm O2 CPAP Valve, Ohmeda Connector O2-MAX Fixed System BiTrac ED Mask, Large Mask & 10.0cm O2-CPAP Valve, Corrugated Tubing, OHM Connector O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 10.0cm O2-CPAP Valve, Expandable Tubing, OHM Connector O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 10.0cm O2-CPAP Valve, Expandable Tubing, Nebulizer O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 10.0cm O2-CPAP Valve, OHM Connector, Nebulizer O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 5 Set O2-CPAP valve O2-MAX Fixed System w/Nebulizer, BiTrac ED Mask, Adult Lg, 5-Set O2 CPAP Valve O2-MAX Fixed System w/Nebulizer, BiTrac ED Mask, Adult Lg, 5-Set O2 CPAP Valve, Ohmeda Connector O2-MAX Fixed System w/Nebulizer, BiTrac ED Mask, Adult Lg, 5-Set O2 CPAP Valve, Schrader Connector O2-MAX Fixed System w/ BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, Corrugated tubing O2-MAX Fixed System w/ BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, Corrugated tubing, AGA Connector O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 3-Set O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 3-Set O2-CPAP valve, Ohmeda Connector O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 3-Set O2-CPAP valve, Chemtron Connector O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 3-Set O2-CPAP valve, American Gas Connector O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 3-Set O2-CPAP valve, Belgium Connector O2-MAX Fixed System w/Nebulizer, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve O2-MAX Fixed System w/Nebulizer, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, Ohmeda Connector O2-MAX Fixed System W/Nebulizer, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, Chemtron Connector O2-MAX Fixed System BiTrac ED Mask -Adult Med, 3-Set O2-CPAP valve O2-MAX Fixed System BiTrac ED Mask -Adult Med, 3-Set O2-CPAP valve, Ohmeda Connector O2-MAX Fixed System BiTrac ED Mask -Adult Med, 3-Set O2-CPAP valve, Chemtron Connector O2-MAX Fixed System BiTrac ED Mask -Adult Med, 3-Set O2-CPAP valve, American Gas Connector O2-MAX Fixed System BiTrac ED Mask -Adult Med, 3-Set O2-CPAP valve, Belgium Connector O2-MAX Fixed System w/Nebulizer, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve O2-MAX Fixed System w/Nebulizer, BiTrac ED Mask -Adult Med, 3-Set O2-CPAP valve, Ohmeda Connector O2-MAX Trio System W/Nebulizer, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve, Chemtron Connector O2-MAX Fixed System BiTrac ED Mask -Adult Med, 5 Set O2-CPAP valve O2-MAX Fixed System w/Nebulizer, BiTrac ED Mask, Adult Med, 5-Set O2 CPAP Valve O2-MAX Fixed System w/Nebulizer, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve, Ohmeda Connector O2-MAX Fixed System BiTrac ED Mask -Adult Lg, 3-Set O2-CPAP valve, Belgium Connector O2-MAX Fixed System BiTrac ED Mask -Adult Med, 3-Set O2-CPAP valve, Belgium Connector O2-MAX Fixed System BiTrac ED Mask -Adult Med, 3-Set O2-CPAP valve O2-MAX Trio Control Unit O2-MAX Trio Control Unit- American Gas Connector O2-MAX Trio Control Unit- British Gas Connector O2-MAX Trio System, BiTrac ED Mask, Adult Med, 5.0cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Med, 5.0cm O2 CPAP Valve- American Connector O2-MAX Trio System, BiTrac ED Mask, Adult Med, 7.5cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Med, 10.0cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Med, 12.5cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Med, 15.0cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Med, 20.0cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve- American Connector O2-MAX Trio System, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve- Schrader Connector O2-MAX Trio System, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve- American Gas Connector O2-MAX Trio System, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve-German Connector O2-MAX Trio System w/Nebulizer, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve O2-MAX Trio System W/Nebulizer, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve, German & French Connects O2-MAX Trio System W/Nebulizer, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve, Chemtron Connector O2-MAX Trio System W/Nebulizer, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve, American Gas Connector O2-MAX Trio System, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve -American Connector O2-MAX Trio System, BiTrac ED Mask, Adult Med, 5-SET O2-CPAP Valve, Corrugated Tubing O2-MAX Trio System, BiTrac ED Mask, Adult Med, 5-Set O2 CPAP Valve- Schrader Connector O2-MAX Trio System, BiTrac ED Mask, Adult Med, 5.0cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Med, 5-Set O2 CPAP Valve- American Gas Connector O2-MAX Trio System w/Nebulizer, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve, Ohmeda Connector O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 5-Set O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 5-Set O2 CPAP Valve- American Gas Connector O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 7.5cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 7.5cm O2 CPAP Valve- American Gas Connector O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 10.0cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 12.5cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 15.0cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 20.0cm O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve- American Gas Connector O2-MAX Trio Systems,BiTrac ED Full Face Mask & Headstrap, 72" Anti-Asphyxia Circuit w/CPAP Valve, Variable Flow Generator w/120" O2 Hose, 3-SET 02-CPAP Valve , Corrugated Tubing, SCH Connector, Neb,LG O2-MAX Trio Systems, BiTrac ED Full Face Mask & Headstrap, 72" Anti-Asphyxia Circuit w/CPAP Valve, Variable Flow Generator w/120" O2 Hose, 3-SET O2-CPAP Valve, Corrugated Tubing, AGA Connector, Nebulizer , Lg O2-MAX Trio Systems,BiTrac ED Full Face Mask & Headstrap, 72" Anti-Asphyxia Circuit w/CPAP Valve, Variable Flow Generator w/120" O2 Hose, 3-SET 02-CPAP Valve , Corrugated Tubing, DIN Connector, Nebulizer, Lg O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, 3-SET O2-CPAP Valve ,Expandable Tubing, UNI Connector, Lg O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, 3-SET O2-CPAP Valve, DIN & NF Connector, Lg O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve- American Gas Connector O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve- French Connector O2-MAX Trio System W/Nebulizer, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve,Expandable Tubing, Nebulizer O2-MAX Trio System w/Nebulizer, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve O2-MAX Trio System W/Nebulizer, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, German & French Connects O2-MAX Trio System W/Nebulizer, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, Expandable Tubing, NF & UNI Connector, Nebulizer O2-MAX Trio System W/Nebulizer, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, American Gas Connector O2-MAX Trio System W/Nebulizer, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, Expandable Tubing, AGA Connector, Nebulizer O2-MAX Trio System W/Nebulizer, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, Expandable Tubing, DIN Connector, Nebulizer O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 5-Set O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Med, 5-Set O2 CPAP Valve- Belgium Connector O2-MAX Trio System w/Nebulizer, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, Ohmeda Connector O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 5-Set O2 CPAP Valve- Belgium Connector O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 5-Set O2 CPAP Valve, Smooth ID Tubing, DIN & NF Connectors, Nebulizer O2-MAX Trio System, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve O2-MAX Trio System, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve, UNI Connector O2-MAX Trio System, BiTrac ED Mask, Adult Med, 5-Set O2 CPAP Valve O2-MAX Trio System, FF BiTrac ED Mask, Adult Lg, 3-SET O2-CPAP Valve, Expandable Tubing O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, UNI Connector O2-MAX Trio System, FF BiTrac ED Mask, Adult Lg, 5-Set O2 CPAP Valve, Expandable 72" Anti-Asphyxia Circuit, O2 Hose with DISS Connector, Adapter 22mmM X 30mmM, Corrugated tubing O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 5-Set O2 CPAP Valve O2-MAX Trio System, 3-Set O2 CPAP Valve, UNI Connector O2-MAX Trio System, 3-Set O2 CPAP Valve, AFNOR Connector O2-MAX Trio System, BiTrac Sm Maxshield Mask, 3-SET 02-CPAP Valve, Smooth ID Tubing O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve, UNI Connector O2-MAX Trio System, BiTrac ED Mask, Adult Lg, 3-Set O2 CPAP Valve- French Connector O2-MAX Trio System, BiTrac ED Mask, Adult Med, 3-Set O2 CPAP Valve No Mask, 3-SET O2-CPAP Valve, Corrugated Tubing No Mask, 3-SET O2-CPAP Valve, Expandable Tubing O2-MAX Trio System, No Mask, No O2-CPAP Valve, Smooth ID Tubing
Model Identifier(s)
313-7435X 313-7438X 313-7456X 313-7457X 313-7461 313-7490X 313-7533X 313-7533X-5 313-7534X 313-7535X 313-7535X-5 313-7536-5 313-7536X 313-7537X 313-7538X 313-7538X-1 313-7538XN 313-7538XN-1 313-7539-1 313-7539X-1 313-7539XN 313-7539XN-1 313-7554X 313-7554XN 313-7554XN-1 313-7554XN-4 313-7555 313-7555-5 313-7555X 313-7555X-1 313-7555X-2 313-7555X-5 313-7555X-9 313-7555XN 313-7555XN-1 313-7555XN-2 313-7556X 313-7556X-1 313-7556X-2 313-7556X-5 313-7556X-9 313-7556XN 313-7556XN-1 313-7556XN-2 313-7557X 313-7557XN 313-7557XN-1 313-7745X-9 313-7746X-9 313-7756X 313-8000 313-8000-5 313-8000-8 313-8001X 313-8001X-5 313-8002X 313-8003X 313-8004X 313-8005X 313-8006X 313-8007-5 313-8007X 313-8007X-4 313-8007X-5 313-8007X-6 313-8007XN-1 313-8007XN-13 313-8007XN-2 313-8007XN-5 313-8007XN-5B 313-8008 313-8008-4 313-8008X 313-8008X-5 313-8009XN-1 313-8011X 313-8011X-5 313-8012X 313-8012X-5 313-8013X 313-8014X 313-8015X 313-8016X 313-8017-5 313-8017N-4 313-8017N-5 313-8017N-6 313-8017X 313-8017X-11 313-8017X-13 313-8017X-5 313-8017X-7 313-8017XN 313-8017XN-1 313-8017XN-13 313-8017XN-14 313-8017XN-5 313-8017XN-5B 313-8017XN-6 313-8018X 313-8019X-9 313-8019XN-1 313-8020X-9 313-8028N-13 313-8107X 313-8107X-11 313-8108X 313-8117X 313-8117X-11 313-8118 313-8118X 313-8119-11 313-8119-7 313-8120 313-8121-11 313-8121-7 313-8131X 313-8200 313-8201X 313-8202