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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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Isotemp™ - 00815773020533

IUEC06386LA, Chest ULT 3 cu. ft., 115V, 60Hz
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
IUEC06386LA
In Commercial Distribution

  • 00815773020533 ()
IUEC06386LA

  • Ultralow-temperature laboratory freezer

Thermo Scientific ™ - 00815773020526

TDEC39686LV, Chest ULT 20 cu. ft., 230V, 50Hz
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
TDEC39686LV
In Commercial Distribution

  • 00815773020526 ()
TDEC39686LV

  • Ultralow-temperature laboratory freezer

Thermo Scientific ™ - 00815773020519

TDEC39686LD, Chest ULT 20 cu. ft., 208-230V, 60Hz
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
TDEC39686LD
In Commercial Distribution

  • 00815773020519 ()
TDEC39686LD

  • Ultralow-temperature laboratory freezer

NA - 03596010566270

MTO CABLE 3.5MM MONO HOOK UP 50 FT
Smith & Nephew, Inc.
7209848
In Commercial Distribution

  • 03596010566270 ()
7209848

  • Electrical-only medical device connection cable, reusable

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™ - 00816394021589

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

  • 00816394021589 ()


  • 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

i.Series® - 00816394021572

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

  • 00816394021572 ()


  • Blood plasma freezer

Horizon Series™ - 00816394020551

-30°C Plasma Storage Freezer, 25 cu ft
HELMER, INC.
HPF125
In Commercial Distribution

  • 00816394020551 ()


  • Blood plasma freezer
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