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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 - 00763000618735

CUSTOM PACK BB11U53R E HEART L
MEDTRONIC, INC.
BB11U53R
In Commercial Distribution

  • 00763000618735 ()


  • Cardiopulmonary bypass system blood tubing set

Medline Industries, Inc. - 10195327518806

D AND E 2ND TRIMESTER PACK
MEDLINE INDUSTRIES, INC.
DYNJ82171A
In Commercial Distribution

  • 40195327518807 ()
  • 10195327518806 ()
DYNJ82171A

  • General surgical procedure kit, non-medicated, single-use

Newport - 10884521541047

e360 Ventilator with Accessories;E Model
Covidien LP
E360P-SY-NA
Not in Commercial Distribution

  • 10884521541047 ()
E360P-SY-NA

  • Neonatal/adult intensive-care ventilator

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

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

QC Sets and Panels: Helix Elite™ - 70845357041097

BD MAX™ Enteric Parasite 20-Day QC Panel
MICROBIOLOGICS INC.
8202 BD MAX™ Enteric Parasite 20-Day QC Panel
In Commercial Distribution

  • 70845357041097 ()
8202

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Xpert Norovirus - 07332940000974

Xpert Norovirus kit; 10 test kit
CEPHEID
GXNOV-10
In Commercial Distribution

  • 07332940000974 ()
GXNOV-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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