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Pulmodyne Aero-Sat™ Heat Moisture Exchanger/Filters - HSA Registration DE0504061

Access comprehensive regulatory information for Pulmodyne Aero-Sat™ Heat Moisture Exchanger/Filters in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504061 and owned by Pulmodyne, Inc.. The device was registered on January 23, 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
DE0504061
Pulmodyne Aero-Sat™ Heat Moisture Exchanger/Filters
HSA Registration Number: DE0504061
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Product Description

The Heat Moisture Exchanger (HME) is intended to provide humidification during breathing through artificial airways. The combined HMEF is intended to provide humidification and filtration during breathing through artificial airways. Expert clinical judgement must be used in assessing the patients' humidification requirements.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0504061
Registration Date
January 23, 2020
Retention Due Date
January 22, 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)
Aero-Sat™ 1 Straight (Sterile) Aero-Sat™ 1 Straight Aero-Sat™ 1 Straight w/Port (Sterile) Aero-Sat™ 1 Straight w/Port Aero-Sat™ 2 Angled (Sterile) Aero-Sat™ 2 Angled Aero-Sat™ 2 Straight (Sterile) Aero-Sat™ 2 Straight Aero-Sat™ Mini (Sterile) Aero-Sat™ Mini Aero-Sat™ Micro + 3.0 (Sterile) Aero-Sat™ Micro + 3.0 Aero-Sat™ Micro + 3.5 (Sterile) Aero-Sat™ Micro + 3.5 Aero-Sat™ Filter Compact Straight (Sterile) Aero-Sat™ Filter Compact Straight Aero-Sat™ Filter Compact Angle (Sterile) Aero-Sat™ Filter Compact Angle Aero-Sat™ Filter Pedi (Sterile) Aero-Sat™ Filter Pedi Aero-Sat™ Filter Small Straight (Sterile) Aero-Sat™ Filter Small Straight Aero-Sat™ Filter Small Angled (Sterile) Aero-Sat™ Filter Small Angled Aero-Sat™HEPA (Sterile) Aero-Sat™HEPA
Model Identifier(s)
101 102 201 202 401 402 601 602 701 702 1101 1102 1201 1202 100801 100802 100901 100902 101001 101002 102301 102302 102401 102402 102901 102902