Singapore HSA registration DE0015562
Respironics OmniLab Advanced + Ventilator System
Singapore·CLASS C·Respironics, Inc.·Registered May 27, 2014Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
- HSA Product Code
- HSAMDC00102
- HS Code
- 90200000
Registration information
- Registration Number
- DE0015562
- Registration Date
- May 27, 2014
- Change Notification Approval Date
- November 23, 2021
- Retention Due Date
- May 26, 2025
Product description
The OmniLab Advanced + is intended to provide non-invasive ventilation for pediatric patients 7 years or older >18.2 kg (40 lbs) with Respiratory Insufficiency or Obstructive Sleep Apnea (OSA). It is also intended to treat adult patients >30 kg (66 lbs) with Respiratory Insufficiency or Obstructive Sleep Apnea caused by central and/or mixed apneas and periodic breathing. The device is intended for use in the hospital.
Product Owner
- Short Name
- Respironics, Inc.
- Address
- 1001 Murry Ridge Lane, Murrysville, PA 15668, UNITED STATES
Registrant
- Address
- 622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
- Address
- 25 LI HWAN TERRACE, GOLDEN HILL ESTATE, SINGAPORE 556953 17 KAKI BUKIT PLACE, EUNOS TECHPARK, #---, SINGAPORE 416195 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880 622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763 2 VENTURE DRIVE, VISION EXCHANGE, #22-28, SINGAPORE 608526
Model information
- Model Name(s)
- Analog Output Module Philips RI Water Chamber OmniLab Connect Respironics OmniLab Advanced + International Respironics OmniLab Advanced + International With Humidifier Respironics OmniLab Advanced + International With Heated Tube Humidifier OmniLab Direct Software, Omnilab Direct, Web Respironics System One Heated Tube
- Model Identifier(s)
- 1006966 1063785 1111076 1111125 1111126 1111127 1112033 1113127 SYS1HT15
About this record
Access comprehensive regulatory information for Respironics OmniLab Advanced + Ventilator System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0015562 and owned by Respironics, Inc.. The device was registered on May 27, 2014.
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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