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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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Vital Cath Pack
Aligned Medical Solutions
AMS9083E
In Commercial Distribution

  • B098AMS9083E1 ()
  • BO98AMS9083E0 ()
AMS9083E

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
Breast Biopsy Pack (24771)
Aligned Medical Solutions
AMS6572B
In Commercial Distribution

  • B098AMS6572B1 ()
  • BO98AMS6572B0 ()
AMS6572B

  • General surgical procedure kit, medicated
Cellular weight scale with a large platform and high weight capacity
Blackbox Remote Patient Monitoring LLC
WS-501C
In Commercial Distribution

  • BB4B963WS501C1 ()
  • B963WS501C0 ()


  • Stand-on floor scale, electronic
Pulse Oximeter
Blackbox Remote Patient Monitoring LLC
PO-401W
In Commercial Distribution

  • BB4B963PO401W1 ()
  • B963PO401W1 ()


  • Pulse oximeter
Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.
Blackbox Remote Patient Monitoring LLC
BPM-201W
Not in Commercial Distribution

  • B963BPM201W1 ()
  • BB1BB963201W1 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Cellular Blood Pressure monitor
Blackbox Remote Patient Monitoring LLC
BPM-102C
In Commercial Distribution

  • B963102C1 ()
  • B963BB10BPM102C10 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Cellular Blood Pressure Monitor
Blackbox Remote Patient Monitoring LLC
BPM-101C
In Commercial Distribution

  • B963101C1 ()
  • BB1BB963101C1 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
ASTM Level 3 Surgical Mask
Fssc LLC
IFM-SM3
In Commercial Distribution

  • B959IFMSM31 ()
  • B959IFMSM30 ()
  • B959IFMSM300 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
Dormia 2Fr 8mm Stone Extractor
EPflex Feinwerktechnik GmbH.
DOF208
In Commercial Distribution

  • B937DOF2081 ()
  • B937DOF2080 ()
DOF208

  • Urinary stone retrieval basket, single-use
Dormia 2Fr 11mm Stone Extractor
EPflex Feinwerktechnik GmbH.
DOF201
In Commercial Distribution

  • B937DOF2011 ()
  • B937DOF2010 ()
DOF201

  • Urinary stone retrieval basket, single-use
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