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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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t:slim X2 5.0 Insulin Pump, Replacement
Tandem Diabetes Care, Inc.
1003487
In Commercial Distribution

  • 00853052007967 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system
t:slim X2 Insulin Pump with Basal-IQ, Refurbished, 6.0
Tandem Diabetes Care, Inc.
1000912
In Commercial Distribution

  • 00853052007325 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system
t:slim X2 5.0 Insulin Pump, Refurbished
Tandem Diabetes Care, Inc.
1000911
In Commercial Distribution

  • 00853052007318 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system
t:slim X2 Insulin Pump with Basal-IQ, Reconditioned, 6.0
Tandem Diabetes Care, Inc.
1000898
In Commercial Distribution

  • 00853052007301 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system
t:slim X2 5.0 Insulin Pump, Reconditioned
Tandem Diabetes Care, Inc.
1000897
In Commercial Distribution

  • 00853052007295 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system
t:slim X2 Insulin Pump with Basal-IQ, Replacement, 6.0
Tandem Diabetes Care, Inc.
1000892
In Commercial Distribution

  • 00853052007288 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system
t:slim X2 5.0 Insulin Pump, Replacement
Tandem Diabetes Care, Inc.
1000891
In Commercial Distribution

  • 00853052007271 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system
t:slim X2 Insulin Pump with Basal-IQ, 6.0
Tandem Diabetes Care, Inc.
1000886
In Commercial Distribution

  • 00853052007264 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system
t:slim X2 5.0 Insulin Pump
Tandem Diabetes Care, Inc.
1000885
In Commercial Distribution

  • 00853052007257 ()


  • Ambulatory insulin infusion pump/blood glucose analyser 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.
900-009-002
In Commercial Distribution

  • 10855728005632 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
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