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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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NA - 00199150021697

CUSTOM PACK BB1B37R38 E WO R
MEDTRONIC, INC.
BB1B37R38
In Commercial Distribution

  • 00199150021697 ()


  • Cardiopulmonary bypass system blood tubing set

T2Bacteria® QCheck Negative Kit - M70885080743

Negative Control for T2Bacteria Panel
T2 BIOSYSTEMS, INC.
85-08074
In Commercial Distribution

  • M70885080743 ()
  • M70883080760 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

T2Bacteria® QCheck Positive Kit - M70885080730

Positive ASK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
85-08073
In Commercial Distribution

  • M70885080730 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

T2Bacteria® QCheck Positive Kit - M70885071910

Positive SK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
85-07191
In Commercial Distribution

  • M70885071910 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

VIVIT Supply - 10810141931401

Commend Nitrile Exam Glove, Chemo Drug Tested, Textured Fingertips, Powder-Free,
Vivit Supply LLC
20121
In Commercial Distribution

  • 20810141931408 ()
  • 10810141931401 ()
  • 00810141931404 ()


  • Total immunoglobulin E (IgE total) IVD, kit, rapid ICT, clinical

Thermoflect - 00612899004184

THERMOFLECT GOWN KIT E, 25 EA TS THERMOFLECT GOWN KIT E, GOWN, CAP, 25 EA NONWOVEN
Encompass Group, L.L.C.
5000-840
In Commercial Distribution

  • 10612899004181 ()
  • 00612899004184 ()


  • Hypothermia-prevention whole-body suit

QC Sets and Panels: Helix Elite™ - 70845357043060

QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8236
In Commercial Distribution

  • 70845357043060 ()
8236

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357042698

QC Sets and Panels: Helix Elite™ Enteric Parasite Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8230
In Commercial Distribution

  • 70845357042698 ()
8230

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041448

QC Sets and Panels: Helix Elite™ Enteric Pathogens Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8184
In Commercial Distribution

  • 70845357041448 ()
8184

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041394

BD MAX™ Enteric Parasite Control Panel
MICROBIOLOGICS INC.
8204 BD MAX™ Enteric Parasite Control Panel
In Commercial Distribution

  • 70845357041394 ()
8204

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
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