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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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
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

  • 16975965297714 ()
  • 06975965297717 ()
  • 86975965295269 ()


  • 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-32-6
In Commercial Distribution

  • 16975965297257 ()
  • 06975965297250 ()
  • 86975965297256 ()


  • 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

  • 16975965297240 ()
  • 06975965297243 ()
  • 86975965297249 ()


  • 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

  • 16975965297233 ()
  • 06975965297236 ()
  • 86975965297232 ()


  • 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-31-6
In Commercial Distribution

  • 16975965297226 ()
  • 06975965297229 ()
  • 86975965297225 ()


  • 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

  • 86975965297218 ()
  • 06975965297212 ()
  • 16975965297219 ()


  • 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-29-12
In Commercial Distribution

  • 86975965297201 ()
  • 06975965297205 ()
  • 16975965297202 ()


  • 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

  • 06975965295928 ()
  • 86975965295924 ()
  • 16975965295925 ()


  • Autoinjector needle
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