HSA · registration DE0509268

Pulmodyne GO-PAP

Name: Pulmodyne GO-PAP — HSA DE0509268
Creator: Pulmodyne, Inc.
Keywords: Pulmodyne GO-PAP, Pulmodyne GO-PAP, DE0509268, Anaesthesiology, HSA

SingaporeAnaesthesiologyClass BPulmodyne, Inc.

Verified

Official record identity

Registration number: DE0509268
Model name: Neb-Connect; GO-PAP, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Small); GO-PAP with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Small); GO-PAP, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium); GO-PAP with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium); GO-PAP plus Neb-Connect, with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium); GO-PAP, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large); GO-PAP with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large); GO-PAP plus Neb-Connect, with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large); GO-PAP, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium); GO-PAP with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium); GO-PAP plus Neb-Connect, with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium); GO-PAP, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large); GO-PAP with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large); GO-PAP plus Neb-Connect, with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large)
Model identifier: 313-011111; 313-4601; 313-4601N; 313-4602; 313-4602N; 313-4602NC; 313-4603; 313-4603N; 313-4603NC; 313-4604; 313-4604N; 313-4604NC; 313-4605; 313-4605N; 313-4605NC
Registration date: May 08, 2024

Classification

Risk class: Class B
Published category: Anaesthesiology

Published parties

Product owner: Pulmodyne, Inc.
Registrant / registration holder: I:EMEDICS PTE. LTD.

Official description

Pulmodyne’s Go-PAP delivers continuous positive airway pressure (CPAP) throughout the breathing cycle. It provides CPAP at preset levels throughout inspiration and exhalation, independent of the patient’s flow rate. Go-PAP system is intended for use on spontaneously breathing patients.

Additional source fields

Product owner address: 2055 Executive Dr, Indianapolis, IN 46241, Indiana, United States
Registrant address: 31 KAKI BUKIT ROAD 3, #05-12, TECHLINK, Singapore 417818

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.