SEARCH RESULTS FOR: 大榄OTC网：(hkotc.cc)kCe4(8507 results)
The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provide a notification to the user.
The Fitbit Irregular Rhythm Notifications is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the Fitbit Irregular Rhythm Notifications is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis.
These data are only captured when the user is still. Along with the user’s risk factors, the Fitbit Irregular Rhythm Notifications can be used to supplement the decision for AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace traditional methods of diagnosis or treatment.
The Fitbit Irregular Rhythm Notifications has not been tested for and is not intended for use
in people under 22 years of age. It is also not intended for use in individuals previously
diagnosed with AFib.
FITBIT, INC.
FB604
In Commercial Distribution
- 00810038852720 ()
FB604
- Cardiopulmonary physiological parameter analysis software
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices.
The products has several models. Different models are distinguished by needle gauge and length.
The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, 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 product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by
providing a shield that covers and locks the needle after use. As the user proceeds with inserting the
needle into the skin the shield will retract. After the injection is completed and needle is removed
from the skin, the shield will automatically extend to cover the needle and lock in place. Once the
Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.
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.
SPN-31-5
In Commercial Distribution
- 56971227400395 ()
- 36971227400391 ()
- 16971227400380 ()
- Autoinjector needle
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices.
The products has several models. Different models are distinguished by needle gauge and length.
The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, 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 product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by
providing a shield that covers and locks the needle after use. As the user proceeds with inserting the
needle into the skin the shield will retract. After the injection is completed and needle is removed
from the skin, the shield will automatically extend to cover the needle and lock in place. Once the
Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.
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.
SPN-30-5
In Commercial Distribution
- 36971227400384 ()
- 16971227400380 ()
- 56971227400388 ()
- Autoinjector needle
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices.
The products has several models. Different models are distinguished by needle gauge and length.
The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, 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 product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by
providing a shield that covers and locks the needle after use. As the user proceeds with inserting the
needle into the skin the shield will retract. After the injection is completed and needle is removed
from the skin, the shield will automatically extend to cover the needle and lock in place. Once the
Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.
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.
SPN-30-8
In Commercial Distribution
- 56971227400371 ()
- 36971227400377 ()
- 16971227400373 ()
- Autoinjector needle
The
products have two types, common type and safety type. Both of the two types 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 Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle
hub, needle container, 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 user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle
is designed to reduce occurrence of accidental needle sticks from patient end of the needle by
providing a shield that covers and locks the needle after use. As the user proceeds with inserting the
needle into the skin the shield will retract. After the injection is completed and needle is removed
from the skin, the shield will automatically extend to cover the needle and lock in place. Once the
Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.
Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle 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
- 36971227400766 ()
- 16971227400762 ()
- Autoinjector needle
The
products have two types, common type and safety type. Both of the two types 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 Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle
hub, needle container, 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 user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle
is designed to reduce occurrence of accidental needle sticks from patient end of the needle by
providing a shield that covers and locks the needle after use. As the user proceeds with inserting the
needle into the skin the shield will retract. After the injection is completed and needle is removed
from the skin, the shield will automatically extend to cover the needle and lock in place. Once the
Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.
Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle 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-32-8
In Commercial Distribution
- 36971227400759 ()
- 16971227400755 ()
- Autoinjector needle
The
products have two types, common type and safety type. Both of the two types 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 Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle
hub, needle container, 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 user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle
is designed to reduce occurrence of accidental needle sticks from patient end of the needle by
providing a shield that covers and locks the needle after use. As the user proceeds with inserting the
needle into the skin the shield will retract. After the injection is completed and needle is removed
from the skin, the shield will automatically extend to cover the needle and lock in place. Once the
Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.
Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle 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
- 36971227400742 ()
- 16971227400748 ()
- Autoinjector needle
The
products have two types, common type and safety type. Both of the two types 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 Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle
hub, needle container, 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 user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle
is designed to reduce occurrence of accidental needle sticks from patient end of the needle by
providing a shield that covers and locks the needle after use. As the user proceeds with inserting the
needle into the skin the shield will retract. After the injection is completed and needle is removed
from the skin, the shield will automatically extend to cover the needle and lock in place. Once the
Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.
Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle 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
- 36971227400735 ()
- 16971227400731 ()
- Autoinjector needle
The
products have two types, common type and safety type. Both of the two types 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 Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle
hub, needle container, 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 user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle
is designed to reduce occurrence of accidental needle sticks from patient end of the needle by
providing a shield that covers and locks the needle after use. As the user proceeds with inserting the
needle into the skin the shield will retract. After the injection is completed and needle is removed
from the skin, the shield will automatically extend to cover the needle and lock in place. Once the
Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.
Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle 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
- 36971227400728 ()
- 16971227400724 ()
- Autoinjector needle
The
products have two types, common type and safety type. Both of the two types 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 Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle
hub, needle container, 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 user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle
is designed to reduce occurrence of accidental needle sticks from patient end of the needle by
providing a shield that covers and locks the needle after use. As the user proceeds with inserting the
needle into the skin the shield will retract. After the injection is completed and needle is removed
from the skin, the shield will automatically extend to cover the needle and lock in place. Once the
Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.
Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle 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-31-6
In Commercial Distribution
- 36971227400711 ()
- 16971227400717 ()
- Autoinjector needle