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PULMODYNE BITRAC SHIELD MASKS & ACCESSORIES - HSA Registration DE0014474

Access comprehensive regulatory information for PULMODYNE BITRAC SHIELD MASKS & ACCESSORIES in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014474 and owned by Pulmodyne, Inc.. The device was registered on December 17, 2013.

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
DE0014474
PULMODYNE BITRAC SHIELD MASKS & ACCESSORIES
HSA Registration Number: DE0014474
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Product Description

The Pulmodyne BiTrac Shield mask is an accessory for use with CPAP or Bilevel systems for ventilatory support. A minimum pressure of > 3.0cm H2O at the mask is required.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00102
HS Code
90200000
Registration Information
Registration Number
DE0014474
Registration Date
December 17, 2013
Change Notification Approval Date
March 06, 2019
Retention Due Date
December 16, 2025
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)
Head Strap with 2 clips (Black) Full Cap Head Gear with 2 clips (Black) Chin Strap (Black) BiTrac Shield Masks BiTrac SE Shield Mask BiTrac MaxShield BiTrac SE MaxShield BiTrac MaxShield BiTrac SE MaxShield BiTrac SE MaxShield BiTrac MaxShield BiTrac Circuit BiTrac Circuit ValueTrac Circuit BiTrac MaxShield Select Pediatric BiTrac MaxShield Select Pediatric BiTrac MaxShield Select Pediatric BiTrac MaxShield Select Pediatric XXS Bonnet XS Bonnet BiTrac MaxShield Select BiTrac MaxShield Select BiTrac MaxShield Select BiTrac MaxShield Select BiTrac MaxShield Select BiTrac MaxShield Select BiTrac Select Interchangable Anti-Asphyxia with Leak Elbow BiTrac Select Interchangable Anti-Asphyxia with Leak Elbow and 22mm Adapter BiTrac Select Interchangable Anti-Asphyxia Nebulizer Elbow BiTrac Select Interchangable Standard Nebulizer Elbow BiTrac Select Interchangable Anti-Asphyxia Bronchoscopy Elbow BiTrac Select Interchangable Standard Bronchoscopy Elbow BiTrac Select Interchangable Anti-Asphyxia Elbow BiTrac SE Select Interchangable Standard Elbow Pediatric Interchangeable Standard (SE) Elbow Pediatric Interchangeable Anti-Asphyxia Elbow
Model Identifier(s)
313-9026 313-9027 313-9029 313-9050W 313-9051W 313-9052W 313-9053W 313-9054W 313-9055W 313-9056W 313-9057W 313-9074 313-9075 313-9078 313-9524 313-9525 313-9526 313-9527 313-9528 313-9529 313-9551 313-9552 313-9553 313-9554 313-9555 313-9556 313-9593 313-9593A 313-9594 313-9595 313-9596 313-9597 313-9598 313-9599 313-9601 313-9602