Home GUDID 04713025000158 APEX
Primary DI 04713025000158
Brand APEX
Company Wellell Inc.
Model 9S-007000
Device description iCH Sense
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name BZD Ventilator, Non-Continuous (Respirator)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BZD Ventilator, Non-Continuous (Respirator) Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14713025000155 Package GS1 6 In Commercial Distribution 04713025000158 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14713025000155 14713025000155 04713025000158 04713025000158 4713025000158
GMDN Terms# Term, Definition table Term Definition Home CPAP unit A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.
Regulatory Flags# DUNS number 656413127 Device count 1 Serial number true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00848530109677 CPAP Mask Kit SUNSET HEALTHCARE SOLUTIONS, INC. BZD 2026-08-15 00848530109684 CPAP Mask Kit SUNSET HEALTHCARE SOLUTIONS, INC. BZD 2026-08-15 00198843003606 Infant Flow™ Zoll Medical Corporation BZD 2026-08-14 00198843003613 Infant Flow™ Zoll Medical Corporation BZD 2026-08-14 00198843003620 Infant Flow™ Zoll Medical Corporation BZD 2026-08-14 00198843003637 Infant Flow™ Zoll Medical Corporation BZD 2026-08-14 00198843003644 Infant Flow™ Zoll Medical Corporation BZD 2026-08-14 00198843003651 Infant Flow™ Zoll Medical Corporation BZD 2026-08-14 00198843003668 Infant Flow™ Zoll Medical Corporation BZD 2026-08-14 00198843003675 Infant Flow™ Zoll Medical Corporation BZD 2026-08-14 00198843003682 Infant Flow™ Zoll Medical Corporation BZD 2026-08-14 00198843003699 Infant Flow™ Zoll Medical Corporation BZD 2026-08-14 06970819423212 RXiBreeze PAP System Resvent Medical Technology Co., Ltd. BZD 2026-08-14 00850088881097 MEDICOLOR Shenzhen Sany Pioneer Technology Co.,Ltd BZD 2026-07-24 00850088881103 MEDICOLOR Shenzhen Sany Pioneer Technology Co.,Ltd BZD 2026-07-24 00850088881035 IBEET Shenzhen Sany Pioneer Technology Co.,Ltd BZD 2026-07-14 00850088881042 IBEET Shenzhen Sany Pioneer Technology Co.,Ltd BZD 2026-07-14 00850088881059 MEDICOLOR Shenzhen Sany Pioneer Technology Co.,Ltd BZD 2026-07-14 00850088881066 MEDICOLOR Shenzhen Sany Pioneer Technology Co.,Ltd BZD 2026-07-14 00850088881028 ItAll Shenzhen Sany Pioneer Technology Co.,Ltd BZD 2026-07-09 00198843003347 Infant Flow™ Zoll Medical Corporation BZD 2026-06-24 00198843003361 Infant Flow™ Zoll Medical Corporation BZD 2026-06-24 00198843003385 Infant Flow™ Zoll Medical Corporation BZD 2026-06-24 00198843003408 Infant Flow™ Zoll Medical Corporation BZD 2026-06-24 00198843003422 Infant Flow™ Zoll Medical Corporation BZD 2026-06-24 00198843003545 Infant Flow™ Zoll Medical Corporation BZD 2026-06-24 00198843003552 Infant Flow™ Zoll Medical Corporation BZD 2026-06-24 00198843003569 Infant Flow™ Zoll Medical Corporation BZD 2026-06-24 00198843003576 Infant Flow™ Zoll Medical Corporation BZD 2026-06-24 00198843003583 Infant Flow™ Zoll Medical Corporation BZD 2026-06-24