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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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One box of RHA® 4 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173230052) is defined as unit of sales and identified with a serial number.
Teoxane SA
RHA® 4 (1mL)
Not in Commercial Distribution

  • 07640173230069 ()
  • 07640173230052 ()
940009

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
One box of RHA® 3 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (27G 1/2). Box Packaging (ID 07640173230038) is defined as unit of sales and identified with a serial number.
Teoxane SA
RHA® 3 (1mL)
Not in Commercial Distribution

  • 07640173230038 ()
  • 07640173230045 ()
940008

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173230014) is defined as unit of sales and identified with a serial number.
Teoxane SA
RHA® 2 (1mL)
Not in Commercial Distribution

  • 07640173230021 ()
  • 07640173230014 ()
940007

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.200
In Commercial Distribution

  • 15051716000008 ()
TB.200US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.300
In Commercial Distribution

  • 15051716000305 ()
TB.300US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of M.Tuberculosis infection in conjunction with risk assessment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.50
In Commercial Distribution

  • 15051716000046 ()
TB.50US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
The Catheter Revision Kit is a sterile kit designed to facilitate the replacement of a section of the intrathecal catheter. A replacement catheter segment is provided with a catheter connector (and sleeve) to allow this segment to be attached to the existing catheter.
Flowonix Medical, Inc.
11830
In Commercial Distribution

  • 00810335020105 ()


  • Spinal infusion/drainage catheter
"One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1mL prefilled syringe and two needles (30G 1/2). Box Packaging (ID 07640173233695) is defined as unit of sales and identified with a serial number."
Teoxane SA
RHA® 2 US 1ml Schott/2 aig. TSK 30G1/2
Not in Commercial Distribution

  • 07640173233671 ()
  • 07640173233695 ()
940007/01

  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main delivery system; it has its own NO generator and gas flow delivery system. Backup NO flow can be delivered to one of two different locations by using the System Selector switch located on the front panel of the LungFit PH system. When the Selector Switch is turned to “Bagging System” position, the backup NO module turns on and delivers 1 L/min of 220 ppm of NO through a separate internal NO2 filter to the Bagging System connector on the front panel of the LungFit PH system. The Bagging System connector has two tubing fittings: one for connecting to an air/oxygen source through oxygen tubing or equivalent to provide an external flow of air/oxygen and the other to connect to a manual resuscitator for manually ventilating a patient. The 1 L/min NO flow from the backup NO module is added to this air/oxygen flow which dilutes the NO concentration down to therapeutic levels. Final NO concentration will depend on the amount of external flow added; for example, a flow of 10 L/min will provide 20 ppm of NO to the patient.
Beyond Air, Inc.
90005
In Commercial Distribution

  • B882900051 ()
  • B882900050 ()
  • B882900052 ()


  • Nitric oxide delivery unit, system-based
Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution

  • 40301937283350 ()
  • 00301937283352 ()
  • 0193-7283-35 ()
  • 00301937283017 ()
84698032

  • Glucose monitoring system IVD, home-use
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