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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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i.Series® - 00816394020513

-30°C Plasma Storage Freezer, 25 cu ft
HELMER, INC.
iPF125
In Commercial Distribution

  • 00816394020513 ()


  • Blood plasma freezer

i.Series® - 00816394020506

-30°C Plasma Storage Freezer, 20 cu ft
HELMER, INC.
iPF120
In Commercial Distribution

  • 00816394020506 ()


  • Blood plasma freezer

i.Series® - 00816394021633

Ultra-Low Freezer, 24 cu ft Added by mistake
HELMER, INC.
iUF124-GX
Not in Commercial Distribution

  • 00816394021633 ()


  • Blood plasma freezer

Horizon Series™ - 00816394021602

-30°C Blood Bank Freezer, 25 cu ft
HELMER, INC.
HBF125-GX
In Commercial Distribution

  • 00816394021602 ()


  • Blood plasma freezer

i.Series® - 00816394021596

-30°C Blood Bank Freezer, 25 cu ft
HELMER, INC.
iBF125-GX
In Commercial Distribution

  • 00816394021596 ()


  • Blood plasma freezer

Horizon Series™ - 00816394021589

-30°C Blood Bank Freezer, 20 cu ft
HELMER, INC.
HBF120-GX
In Commercial Distribution

  • 00816394021589 ()


  • Blood plasma freezer

i.Series® - 00816394021572

-30°C Blood Bank Freezer, 20 cu ft
HELMER, INC.
iBF120-GX
In Commercial Distribution

  • 00816394021572 ()


  • Blood plasma freezer

ECG Patient Cable - 00816396021716

ECG Patient Cable, Shielded, 4-Lead, IEC, 10 ft
IVY BIOMEDICAL SYSTEMS, INC.
590446
In Commercial Distribution

  • 00816396021716 ()

  • Length: 10 Feet
590446

  • Electrocardiographic lead set, reusable

ECG Patient Cable - 00816396021679

ECG Patient Cable, Shielded, 4-Lead, AHA, 10 ft
IVY BIOMEDICAL SYSTEMS, INC.
590432
In Commercial Distribution

  • 00816396021679 ()

  • Length: 10 Feet
590432

  • Electrocardiographic lead set, reusable

ECG Patient Cable - 00816396021594

ECG Patient Cable, Shielded, 3-Lead, IEC, 10 ft
IVY BIOMEDICAL SYSTEMS, INC.
590408
In Commercial Distribution

  • 00816396021594 ()

  • Length: 10 Feet
590408

  • Electrocardiographic lead set, reusable
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