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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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Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120 syringe infusion pump. Elite Biomedical Solutions does not manufacture the pump. The Dose Request Cord is an accessory for the pump and is available as a replacement part. The Dose Request Cord contains a handpiece with integral cable which plugs into the mating connector on the BD Alaris PCA Pump to allow the patient to request medication within the parameters entered into the syringe/infusion pump by the healthcare provider and the designed limits on the pumps. The Elite Biomedical Solutions Dose Request Cord has the same type of construction and technological characteristics as the predicate device, which is also a replacement bolus cable. Both the subject and predicate device are equivalent to the accessories supplied with the original pump. The Dose Request Cords are passive devices that contain no powered electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device.
Elite Biomedical Solutions LLC
B
In Commercial Distribution

  • 00860008635402 ()
10013795 EBS

  • Infusion pump remote control
The SuperBall Meniscal Repair System is a single patient, single use, an all-inside, all-suture meniscal repair device.
ARCURO MEDICAL LTD
B
In Commercial Distribution

  • 00850000630017 ()
SBD-SB-12-001

  • Polyester suture, non-bioabsorbable, multifilament
To support drape over patient face
ADEPT MEDICAL LIMITED
B
In Commercial Distribution

  • 09421905187589 ()
AM1000B

  • Radiological arm/leg positioner
Support patient arm
ADEPT MEDICAL LIMITED
B
In Commercial Distribution

  • 09421905187572 ()
AM0180

  • Radiological arm/leg positioner
To support the sterile drape over the patient.
ADEPT MEDICAL LIMITED
B
In Commercial Distribution

  • 09421905187411 ()
AM1000B

  • Bedding support
No Description
Merit Medical Systems, Inc.
B
In Commercial Distribution

  • 10884450021269 ()
  • 00884450021262 ()
  • 20884450021266 ()
IN9152

  • Catheter/overtube balloon inflator, single-use
No Description
LUCERNO DYNAMICS, LLC
B
In Commercial Distribution

  • 00850014578251 ()
  • 00850014578107 ()
401874-285

  • Scintillation-counter radiation survey meter
No Description
LUCERNO DYNAMICS, LLC
B
In Commercial Distribution

  • 00850014578169 ()
  • 00850014578008 ()
401874-230

  • Scintillation-counter radiation survey meter
Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "B" is labeled for connections to electrodes 65-128.
NEURALYNX, INC.
-B
In Commercial Distribution

  • 00850011306383 ()
31-0602-0034

  • Electrical-only medical device connection cable, reusable
prolaio Convenience Kit - Model B
Prolaio, Inc.
B
In Commercial Distribution

  • 00850071330090 ()


  • Electrocardiography monitoring system receiver
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