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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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STRAP, URINE COLLECTION, LATEX, BUTTONS, REUSABLE, REPLACEMENT, SET OF 3 Replacement Latex Leg Straps for use with all Urocare Latex Urine Collection Leg Bags and Male Urinal Systems.
UROCARE PRODUCTS, INC.
6006
In Commercial Distribution

  • 10792293060065 ()
  • 00792293060068 ()

  • Depth: 0.06 Inch
  • Width: 0.75 Inch
  • Length: 21.75 Inch
  • Weight: 0.02 Pound
6006

  • Open-ended wearable urine collection bag, non-sterile
  • Penis/scrotum wearable urinal
iReliev PlayMakar Expandable Wireless Pods
EXCELHEALTH, INC.
ET-5555
In Commercial Distribution

  • 10853635002447 ()
  • 00853635002440 ()
ET-5555

  • Arthritis TENS system
  • Transcutaneous electrical stimulation electrode, single-use
  • Analgesic transcutaneous electrical nerve stimulation system
PRESSURE MONITORING ACCESSORY
Edwards Lifesciences LLC
MK2220
In Commercial Distribution

  • 00690103148190 ()
  • 50690103148195 ()
MK2220

  • Invasive blood pressure monitoring tubing set
  • Cable/lead/sensor/probe cover, sterile
16FR x 1.7cm Mini ONE Balloon Button (Boxed Kit) Low Profile Feeding Device
APPLIED MEDICAL TECHNOLOGY, INC.
M1-5-1617
In Commercial Distribution

  • 00842071100322 ()

  • Catheter Gauge: 16 French
  • Length: 1.7 Centimeter


  • Gastrostomy button
  • Enteral feeding kit, adult/paediatric, sterile
  • Enteral feeding kit, infant
12FR x 5.5 cm Mini ONE® Balloon Button (Boxed Kit - I) Low Profile Feeding Device
APPLIED MEDICAL TECHNOLOGY, INC.
M1-5-1255-I
In Commercial Distribution

  • 00842071119720 ()

  • Length: 5.5 Centimeter
  • Catheter Gauge: 12 French
M1-5-1255-I

  • Gastrostomy button
  • Enteral feeding kit, adult/paediatric, sterile
  • Enteral feeding kit, infant
Amplichek II Level 3 MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000578
In Commercial Distribution

  • 00847661005995 ()
12000578

  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
Amplichek II Level 2 MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000577
In Commercial Distribution

  • 00847661005988 ()
12000577

  • MRSA nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
Amplichek II Level 1 MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000576
In Commercial Distribution

  • 00847661005971 ()
12000576

  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
Amplichek II Negative MiniPak (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000575
In Commercial Distribution

  • 00847661005964 ()
12000575

  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
Amplichek II Level 3 (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000204
In Commercial Distribution

  • 00847661005957 ()
12000204

  • MRSA nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
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