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PULMODYNE BITRAC FACE MASKS & ACCESSORIES - HSA Registration DE0014475

Access comprehensive regulatory information for PULMODYNE BITRAC FACE 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 DE0014475 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
DE0014475
PULMODYNE BITRAC FACE MASKS & ACCESSORIES
HSA Registration Number: DE0014475
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Product Description

The BiTrac NIV Full Face mask is an accessory for use with CPAP or Bilevel systems used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilatory support.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00102
HS Code
90200000
Registration Information
Registration Number
DE0014475
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)
BiTrac Full Face Mask BiTrac Full Face Mask BiTrac Full Face Mask BiTrac Full Face Mask BiTrac SE Full Face Mask BiTrac SE Full Face Mask BiTrac SE Full Face Mask BiTrac SE Full Face Mask Head Strap with 2 clips (Black) Full Cap Head Gear with 2 clips (Black) Chin Strap (Black) BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Circuit BiTrac Circuit ValueTrac Circuit BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac SE Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask BiTrac Select Full Face Mask 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
Model Identifier(s)
313-9001W 313-9002W 313-9003W 313-9004W 313-9009W 313-9010W 313-9011W 313-9012W 313-9026 313-9027 313-9029 313-9031W 313-9032W 313-9033W 313-9034W 313-9035W 313-9036W 313-9037W 313-9038W 313-9042W 313-9043W 313-9044W 313-9046W 313-9047W 313-9048W 313-9062W 313-9063W 313-9064W 313-9066W 313-9067W 313-9068W 313-9074 313-9075 313-9078 313-9501 313-9502 313-9503 313-9504 313-9506 313-9507 313-9508 313-9509 313-9511 313-9512 313-9513 313-9514 313-9530 313-9531 313-9532 313-9533 313-9535 313-9536 313-9537 313-9538 313-9541 313-9542 313-9543 313-9546 313-9547 313-9548 313-9561 313-9562 313-9563 313-9566 313-9567 313-9568 313-9571 313-9572 313-9573 313-9576 313-9576A 313-9577 313-9577A 313-9578 313-9578A 313-9580 313-9581 313-9582 313-9583 313-9593 313-9593A 313-9594 313-9595 313-9596 313-9597 313-9598 313-9599