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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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SYNCHROMED®II - 00763000422615

PUMP 8637-40 SM II 40ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00763000422615 ()


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED®II - 00763000422608

PUMP 8637-20 SM II 20ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00763000422608 ()


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED™ III - 00763000597030

PUMP 8667-40 SYNCHROMEDIII INFUSION EMAN
MEDTRONIC, INC.
8667-40
In Commercial Distribution

  • 00763000597030 ()

  • Reservoir Volume 40 mL


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED™ III - 00763000597023

PUMP 8667-20 SYNCHROMEDIII INFUSION EMAN
MEDTRONIC, INC.
8667-20
In Commercial Distribution

  • 00763000597023 ()

  • Reservoir Volume 20 mL


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED® II - 00763000634100

PUMP 8637-40 SM II 40ML EMAN SYMBL
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00763000634100 ()

  • Reservoir Volume 40 ML


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED® II - 00763000634094

PUMP 8637-20 SM II 20ML EMAN SYMBL
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00763000634094 ()

  • Reservoir Volume 20 ML


  • Implantable intrathecal infusion pump, programmable

DeRoyal - 00749756999274

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164-YL
In Commercial Distribution

  • 50749756999279 ()
  • 00749756999274 ()
M5164-YL

  • Gait rehabilitation system harness

DeRoyal - 00749756977937

Kit W/Blanket and Gait Belt
DEROYAL INDUSTRIES, INC.
MK3045-UBLG
In Commercial Distribution

  • 50749756977932 ()
  • 00749756977937 ()
MK3045-UBLG

  • Gait rehabilitation system harness

DeRoyal - 00749756951784

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672-B
In Commercial Distribution

  • 50749756951789 ()
  • 00749756951784 ()
M2672-B

  • Gait rehabilitation system harness

DeRoyal - 00749756947657

GAIT BELT, WIPEABLE
DEROYAL INDUSTRIES, INC.
M5168-YL
In Commercial Distribution

  • 00749756947657 ()
M5168-YL

  • Gait rehabilitation system harness

DeRoyal - 00749756866309

Gait Belt, Heavy DutyTiger Teeth Buckle, 2 In X 70 In
DEROYAL INDUSTRIES, INC.
M2572
In Commercial Distribution

  • 50749756866304 ()
  • 00749756866309 ()
M2572

  • Gait rehabilitation system harness

DeRoyal - 00749756884440

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5168-Y
In Commercial Distribution

  • 00749756884440 ()
M5168-Y

  • Gait rehabilitation system harness

DeRoyal - 00749756861274

GAIT BELT
DEROYAL INDUSTRIES, INC.
M2660
In Commercial Distribution

  • 50749756861279 ()
  • 00749756861274 ()
M2660

  • Gait rehabilitation system harness

DeRoyal - 00749756847865

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672
In Commercial Distribution

  • 50749756847860 ()
  • 00749756847865 ()
M2672

  • Gait rehabilitation system harness

DeRoyal - 00749756846462

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2656
In Commercial Distribution

  • 00749756846462 ()
M2656

  • Gait rehabilitation system harness

DeRoyal - 00749756797900

HEAVY DUTY GAIT BELT
DEROYAL INDUSTRIES, INC.
400P10
In Commercial Distribution

  • 50749756797905 ()
  • 00749756797900 ()
400P10

  • Gait rehabilitation system harness

DeRoyal - 00749756783286

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166Y
In Commercial Distribution

  • 00749756783286 ()
M5166Y

  • Gait rehabilitation system harness

DeRoyal - 00749756782616

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166Y-72
In Commercial Distribution

  • 00749756782616 ()
M5166Y-72

  • Gait rehabilitation system harness

Prometra Programmable Pump - 00810335020242

Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • Implantable intrathecal infusion pump, programmable

Prometra II Pump - 00810335020228

The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.
Flowonix Medical, Inc.
13827
In Commercial Distribution

  • 00810335020228 ()


  • Implantable intrathecal infusion pump, programmable
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