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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IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0125
Not in Commercial Distribution

  • 00815381020079 ()
RFIT-ASY-0125

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0124
Not in Commercial Distribution

  • 00815381020062 ()
RFIT-ASY-0124

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Aktina Corp.
11-202
In Commercial Distribution

  • B365112020 ()


  • Radiological whole-body positioner
The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only.
ABAXIS, INC.
400-0031
In Commercial Distribution

  • EABA40000311 ()
  • EABA40000310 ()
400-0031

  • Total lactate dehydrogenase (LDH) IVD, reagent
  • Magnesium (Mg2+) IVD, reagent
  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Glucose IVD, reagent
No Description
Bracco Injeneering SA
650197
In Commercial Distribution

  • 37630039300112 ()
  • 17630039300118 ()
650197

  • Contrast medium injection system control unit
One-Piece Malleable (i-skin) Calf Panel for use with Motion Concepts CM Legrests. (Bendable/shape-able integral skin foam pad). One-Size only
Motion Concepts Inc
D-0101-0157-OPMCP
In Commercial Distribution

  • 07540147002480 ()
OPMCP

  • Wheelchair footrest/legrest
  • Wheelchair legrest pad
One-Piece Flat Calf Panel Mount Assy designed for use with Motion Concepts CM Legrests (includes mounting hardware). One-Piece Calf Pad sold separately. Available in a variety of widths and heights to accommodate different user needs.
Motion Concepts Inc
D-0101-0157-OSCPL
In Commercial Distribution

  • 07540147002473 ()
OSCPL

  • Wheelchair footrest/legrest
  • Wheelchair legrest pad
One-Piece Flat Calf Panel Pad use with Motion Concepts CM Legrests. (HR PU foam pad with black polyester fabric cover). Available in a variety of widths and heights to accommodate different user needs. Installs onto the corresponding sized One-Piece Calf Panel Assy.
Motion Concepts Inc
D-0197-OPFCP
In Commercial Distribution

  • 07540147002435 ()
OSFCP

  • Wheelchair footrest/legrest
  • Wheelchair legrest pad
No Description
MAZOR ROBOTICS LTD
MAS1891-05S
In Commercial Distribution

  • 07290115750195 ()


  • Stereotactic surgery system probe, reusable
No Description
DIASORIN MOLECULAR LLC
SC1100
In Commercial Distribution

  • 20816101025101 ()
SC1100

  • Optical laboratory instrument performance standard calibrator/control IVD, reusable
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV900B
In Commercial Distribution

  • 06977717372901 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV600B
In Commercial Distribution

  • 06977717372604 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV300B
In Commercial Distribution

  • 06977717372307 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV2400B
In Commercial Distribution

  • 06977717372246 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV1500B
In Commercial Distribution

  • 06977717372154 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV1000B
In Commercial Distribution

  • 06977717372109 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV750A
In Commercial Distribution

  • 06977717371751 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV6000A
In Commercial Distribution

  • 06977717371621 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV600A
In Commercial Distribution

  • 06977717371607 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV3600A
In Commercial Distribution

  • 06977717371362 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV300A
In Commercial Distribution

  • 06977717371300 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV2400A
In Commercial Distribution

  • 06977717371249 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV200A
In Commercial Distribution

  • 06977717371201 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV1500A
In Commercial Distribution

  • 06977717371157 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV1000A
In Commercial Distribution

  • 06977717371102 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV60A
In Commercial Distribution

  • 06977717371065 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV900
In Commercial Distribution

  • 06977717379900 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV6000
In Commercial Distribution

  • 06977717379627 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV600
In Commercial Distribution

  • 06977717379603 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV4500
In Commercial Distribution

  • 06977717379450 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV3600
In Commercial Distribution

  • 06977717379368 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV300
In Commercial Distribution

  • 06977717379306 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV2400
In Commercial Distribution

  • 06977717379245 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV200
In Commercial Distribution

  • 06977717379207 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV1500
In Commercial Distribution

  • 06977717379153 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV1000
In Commercial Distribution

  • 06977717379108 ()


  • Red/infrared light phototherapy unit
No Description
Shenzhen RedV Medical Equipment CO., LTD
RV60
In Commercial Distribution

  • 06977717379061 ()


  • Red/infrared light phototherapy unit
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801946 ()


  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801427 ()


  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801458 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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