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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 sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-002-010
In Commercial Distribution

  • 10855728005526 ()
4323

  • Implantable sleep apnoea treatment system, respiration-sensing
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-002-009
In Commercial Distribution

  • 10855728005496 ()
4323

  • Implantable sleep apnoea treatment system, respiration-sensing
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-009-001
In Commercial Distribution

  • 10855728005458 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-002-008
In Commercial Distribution

  • 10855728005403 ()
4323

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-002-007
In Commercial Distribution

  • 10855728005199 ()
4323

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself
BAXTER HEALTHCARE CORPORATION
934072
In Commercial Distribution

  • 05413765404634 ()

  • Total Volume: 8 Milliliter
934072

  • Surgical internal adhesive/sealant, synthetic polymer
Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself
BAXTER HEALTHCARE CORPORATION
934071
In Commercial Distribution

  • 05413765404627 ()

  • Total Volume: 4 Milliliter
934071

  • Surgical internal adhesive/sealant, synthetic polymer
Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself
BAXTER HEALTHCARE CORPORATION
934070
In Commercial Distribution

  • 05413765404610 ()

  • Total Volume: 2 Milliliter
934070

  • Surgical internal adhesive/sealant, synthetic polymer
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-002-007
In Commercial Distribution

  • 00855728005192 ()
4323

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration.
Inspire Medical Systems, Inc.
900-002-005
In Commercial Distribution

  • 00855728005000 ()
4323

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
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