Singapore HSA registration DE0012654
Philips Respironics Wisp Nasal Mask
Singapore·CLASS B·Philips Respironics, Inc.·Registered March 28, 2013Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0012654
- Registration Date
- March 28, 2013
- Change Notification Approval Date
- April 15, 2017
- Retention Due Date
- March 27, 2026
Product description
The Wisp Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg), the pediatric nasal mask is to be used on patients 5 kg/11 lbs or greater (≥5 kg/11 lbs) and the youth nasal mask to be used on patients 7 years or older (>40 lbs/18 kg) for whom CPAP or bi-level therapy has been prescribed.
Product Owner
- Short Name
- Philips Respironics, Inc.
- Address
- 1001 Murry Ridge Lane, Murrysville,Pennslyvania 15668-8550, UNITED STATES
Registrant
- Address
- 622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
- Address
- 25 LI HWAN TERRACE, GOLDEN HILL ESTATE, SINGAPORE 556953 3 MOUNT ELIZABETH, MOUNT ELIZABETH HOSPITAL, #12-13, SINGAPORE 228510 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 JALAN RAJAH, GOLDEN WALL FLATTED FACTORY, #05-20, SINGAPORE 329134 246 MACPHERSON ROAD, BETIME BUILDING, #03-01, SINGAPORE 348578
Model information
- Model Name(s)
- Wisp mask clear frame, with headgear Wisp mask fabric frame, with headgear Wisp SE mask clear frame w/ HDGR, Int Wisp headgear, large size Clear frame Fabric frame Wisp headgear Wisp headgear clips Petite cushion Small/medium cushion Large cushion Wisp Ped Fit Pack w/Headgear - EE INT Wisp Ped SCS Cushion RP Wisp Ped SCM Cushion RP Wisp Ped SCL Cushion RP Wisp Ped Frame RP Wisp Ped Headgear RP Wisp Ped Headgear Clip RP Wisp Ped Sizing Gauge RP Wisp Ped SE Elbow Acccessory Wisp Ped Tubing w/Cover Assy RP RS, Wisp Headgear, RP Wisp Youth Nasal Mask Fabric Frame W/Hdgr, Intl
- Model Identifier(s)
- 1094060 1094061 1094062 1094078 1094080 1094081 1094082 1094083 1094086 1094088 1094088 1104961 1104969 1104970 1104971 1104972 1104973 1104974 1104975 1104976 1104977 1109307 1109308
About this record
Access comprehensive regulatory information for Philips Respironics Wisp Nasal Mask in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0012654 and owned by Philips Respironics, Inc.. The device was registered on March 28, 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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