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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No Description
Synapse Biomedical, Inc.
21-0024-99
In Commercial Distribution

  • 00852184003168 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
21-0023-99
In Commercial Distribution

  • 00852184003151 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
21-0025-99
In Commercial Distribution

  • 00852184003175 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
21-0007-99
In Commercial Distribution

  • 00852184003113 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
21-0009-99
In Commercial Distribution

  • 00852184003120 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • Implantable intrathecal infusion pump, programmable
The Prometra 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.
Flowonix Medical, Inc.
11827
In Commercial Distribution

  • 00810335020082 ()


  • Implantable intrathecal infusion pump, programmable
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
No Description
Synapse Biomedical, Inc.
20-0035
In Commercial Distribution

  • 00852184003007 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
20-0031
In Commercial Distribution

  • 00852184003021 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
20-0030
In Commercial Distribution

  • 00852184003014 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
20-0007
In Commercial Distribution

  • 00852184003199 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
20-0039
In Commercial Distribution

  • 00852184003083 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
20-0028
In Commercial Distribution

  • 00852184003038 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
20-0046
In Commercial Distribution

  • 00852184003052 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
20-0036
In Commercial Distribution

  • 00852184003045 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
Models 400 and 550 Implantable Infusion Pump Refill Kit Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set with Removable Injection Site (1) Stopcock (2) Huber Point Needles 22 Gauge x 1inch (2.54 cm) (2) Huber Point Needles 22 Gauge x 1.5inch (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (2) Pump Templates (2) Adhesive Bandages (1) Refill Worksheet (1) Set of INSTRUCTIONS FOR USE
Medos International Sàrl
IP40820US
Not in Commercial Distribution

  • 10886704078845 ()
IP40820US

  • Implantable intrathecal infusion pump, nonprogrammable
FOR USE WITH CODMAN 3000 series IMPLANTABLE DRUG DELIVERY SYSTEM Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set (1) Stopcock (2) Huber Point Needles: 22 Gauge x 1.5" (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (1) Data Sticker (2) Adhesive Bandages (1) Refill Worksheet (1) INSTRUCTIONS FOR USE (2) Instruction Posters
Medos International Sàrl
AP07014US
Not in Commercial Distribution

  • 10886704078838 ()
AP07014US

  • Implantable intrathecal infusion pump, nonprogrammable
Bolus Kit
Medos International Sàrl
91-4284US
In Commercial Distribution

  • 10886704071440 ()
914284US

  • Implantable intrathecal infusion pump, programmable
FOR USE WITH CODMAN 3000 series Refill Kit - CODMAN 3000 Series Implantable Drug Delivery System
Medos International Sàrl
AP-07014
Not in Commercial Distribution

  • 10886704043775 ()
AP07014

  • Implantable intrathecal infusion pump, nonprogrammable
FOR USE WITH: CODMAN 3000 Series Implantable Pump Operating Room Prep Kit Contents: (1) 2.54cm (1 inch) Huber Needle (REF AP-04009) (1) Special Bolus Needle (REF AP-04013-5) (1) Empty Syringe Barrel with Lid assembled to a 33cm (13 inch) Microbore Tubing Set with Clamp Approximate priming volume 0.3mL (3) Instructions for Use Posters
Medos International Sàrl
AP-07004
Not in Commercial Distribution

  • 10886704043768 ()
AP07004

  • Implantable intrathecal infusion pump, nonprogrammable
Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 2inch (5 cm)
Medos International Sàrl
AP-04032-5
Not in Commercial Distribution

  • 20886704043741 ()
  • 10886704043744 ()
AP040325

  • Implantable intrathecal infusion pump, nonprogrammable
Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Medos International Sàrl
AP-04030
Not in Commercial Distribution

  • 20886704043734 ()
  • 10886704043737 ()
AP04030

  • Implantable intrathecal infusion pump, nonprogrammable
Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 1 3/8inch (3.5 cm)
Medos International Sàrl
AP-04013-5
Not in Commercial Distribution

  • 20886704043727 ()
  • 10886704043720 ()
AP040135

  • Implantable intrathecal infusion pump, nonprogrammable
Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Medos International Sàrl
AP-04011
Not in Commercial Distribution

  • 20886704043710 ()
  • 10886704043713 ()
AP04011

  • Implantable intrathecal infusion pump, nonprogrammable
Refill Kit
Medos International Sàrl
91-4287
In Commercial Distribution

  • 10886704072072 ()
914287

  • Implantable intrathecal infusion pump, programmable
Refill Kit
Codman Neuro Sciences Sàrl
91-4285US
In Commercial Distribution

  • 20886704071454 ()
  • 10886704071457 ()
914285US

  • Implantable intrathecal infusion pump, programmable
Refill Kit
Medos International Sàrl
91-4288
In Commercial Distribution

  • 20886704064951 ()
  • 10886704064954 ()
914288

  • Implantable intrathecal infusion pump, programmable
Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
INTERA ONCOLOGY INC.
AP-03000H
In Commercial Distribution

  • 00850014110147 ()

  • Total Volume: 30 Milliliter
AP03000H

  • Implantable intrathecal infusion pump, nonprogrammable
No Description
Synapse Biomedical, Inc.
22-0020
In Commercial Distribution

  • 00852184003380 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
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