SEARCH RESULTS FOR: 大榄OTC网：(hkotc.cc)kCe4(8519 results)
Dream Sock Software App.
The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not
intended to provide notification for every episode of the unexpected occurrences of elevated or
depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only
when sufficient data are available for analysis. The notifications and associated data can be used to
supplement the decision by caregivers to seek additional guidance for medical care of the infant. The
Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.
Owlet Baby Care, Inc.
3.0
In Commercial Distribution
- 00810099090819 ()
- Multiple vital physiological parameter monitoring system, home-use
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094936889 ()
- Patient general health self-management software
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094936872 ()
- Patient general health self-management software
ONE-CARE glucose monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE system can be used at home (over the counter OTC) by persons with diabetes. ONE-CARE glucose meter feature strip ejector for safe removal of used strip, large and user-friendly display, as well as small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips. ONE-CARE glucose monitor automatically powers on and shuts down when the strip is inserted/ejected.
MediVena, LLC
AC500
In Commercial Distribution
- 00810008210451 ()
- 00810008210161 ()
4006
- Glucose monitoring system IVD, home-use
The products are sterile with a
Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has
several models. Different models are distinguished by needle gauge and length.
The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,
needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the
silicone oil is used to needle tube lubrication.
The products are for OTC use, and
they are external communication, blood indirect devices. The contact duration for both subjected
devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-29-12
In Commercial Distribution
- 16971227408720 ()
- 06971227408723 ()
- 86971227408729 ()
- Autoinjector needle
The products are sterile with a
Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has
several models. Different models are distinguished by needle gauge and length.
The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,
needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the
silicone oil is used to needle tube lubrication.
The products are for OTC use, and
they are external communication, blood indirect devices. The contact duration for both subjected
devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-31-5
In Commercial Distribution
- 16971227408713 ()
- 06971227408716 ()
- 86971227408712 ()
- Autoinjector needle
The products are sterile with a
Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has
several models. Different models are distinguished by needle gauge and length.
The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,
needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the
silicone oil is used to needle tube lubrication.
The products are for OTC use, and
they are external communication, blood indirect devices. The contact duration for both subjected
devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-31-8
In Commercial Distribution
- 16971227408706 ()
- 06971227408709 ()
- 86971227408705 ()
- Autoinjector needle
The products are sterile with a
Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has
several models. Different models are distinguished by needle gauge and length.
The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,
needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the
silicone oil is used to needle tube lubrication.
The products are for OTC use, and
they are external communication, blood indirect devices. The contact duration for both subjected
devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-32-5
In Commercial Distribution
- 16971227408690 ()
- 06971227408693 ()
- 86971227408699 ()
- Autoinjector needle
The products are sterile with a
Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has
several models. Different models are distinguished by needle gauge and length.
The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,
needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the
silicone oil is used to needle tube lubrication.
The products are for OTC use, and
they are external communication, blood indirect devices. The contact duration for both subjected
devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-32-4
In Commercial Distribution
- 16971227408683 ()
- 06971227408686 ()
- 86971227408682 ()
- Autoinjector needle
The products are sterile with a
Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has
several models. Different models are distinguished by needle gauge and length.
The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,
needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the
silicone oil is used to needle tube lubrication.
The products are for OTC use, and
they are external communication, blood indirect devices. The contact duration for both subjected
devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-33-4
In Commercial Distribution
- 16971227408676 ()
- 06971227408679 ()
- 86971227408675 ()
- Autoinjector needle