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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CUSTOM PACK CB11G78R 1/4 E
MEDTRONIC, INC.
CB11G78R
In Commercial Distribution

  • 00763000412845 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK HY11H15R2 CONNECT E CL
MEDTRONIC, INC.
HY11H15R2
In Commercial Distribution

  • 00763000411909 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK HY8T53R11 PEDS E PK
MEDTRONIC, INC.
HY8T53R11
In Commercial Distribution

  • 00763000602765 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB8W77R10 ADLT E PK
MEDTRONIC, INC.
CB8W77R10
In Commercial Distribution

  • 00763000602758 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK HY8V48R6 FRN HRT E
MEDTRONIC, INC.
HY8V48R6
In Commercial Distribution

  • 00763000533823 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB7U43R10 3/8 E
MEDTRONIC, INC.
BB7U43R10
In Commercial Distribution

  • 00763000530426 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB1B37R28 E WO R
MEDTRONIC, INC.
CB1B37R28
In Commercial Distribution

  • 00763000274788 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB10X91R2 10PK E. SHUNT
MEDTRONIC, INC.
CB10X91R2
In Commercial Distribution

  • 20763000273433 ()
  • 00763000273422 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 10J05R1 3/8 E
MEDTRONIC, INC.
10J05R1
Not in Commercial Distribution

  • 00763000264680 ()


  • Cardiopulmonary bypass system blood tubing set
C E T, HUFFMAN CATARACT PACK
Cardinal Health 200, LLC
SEY32CELC3
In Commercial Distribution

  • 50195594518385 ()
  • 10195594518387 ()
SEY32CELC3

  • General surgical procedure kit, medicated
CUSTOM PACK CB6S20R17 1/4 E
MEDTRONIC, INC.
CB6S20R17
Not in Commercial Distribution

  • 00763000092153 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK HY1C44R19 1/4 E
MEDTRONIC, INC.
HY1C44R19
Not in Commercial Distribution

  • 00763000089948 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL7U43R9 3/8 E
MEDTRONIC, INC.
TL7U43R9
In Commercial Distribution

  • 00763000146788 ()


  • Cardiopulmonary bypass system blood tubing set
P E T LOCAL PROCEDURE TRAY
Cardinal Health 200, LLC
SNU29LPFS3
In Commercial Distribution

  • 50197106232772 ()
  • 10197106232774 ()
SNU29LPFS3

  • General surgical procedure kit, non-medicated, single-use
Stemmed Femoral Size E, PCK, Right
MAXX ORTHOPEDICS, INC.
RFPSRE00-RK
In Commercial Distribution

  • 00811767022620 ()

  • Length: 62 Millimeter
  • Width: 68 Millimeter


  • Uncoated knee femur prosthesis, metallic
Stemmed Femoral Size E, PCK, Left
MAXX ORTHOPEDICS, INC.
RFPSLE00-RK
In Commercial Distribution

  • 00811767022545 ()

  • Width: 68 Millimeter
  • Length: 62 Millimeter


  • Uncoated knee femur prosthesis, metallic
CUSTOM PACK BB12E45R1 SUPPORT E PK
MEDTRONIC, INC.
BB12E45R1
In Commercial Distribution

  • 00763000927714 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB1B37R37 E WO R
MEDTRONIC, INC.
CB1B37R37
In Commercial Distribution

  • 00763000924607 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB12F51R2 E ASSIST PACK
MEDTRONIC, INC.
BB12F51R2
In Commercial Distribution

  • 00763000953423 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11Y76R2 PEDS E PK
MEDTRONIC, INC.
BB11Y76R2
In Commercial Distribution

  • 00763000913380 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11U53R1 E HEART L
MEDTRONIC, INC.
BB11U53R1
In Commercial Distribution

  • 00763000959821 ()


  • Cardiopulmonary bypass system blood tubing set
PG&E Wilderness Tactical - Trauma Bag
Certified Safety Manufacturing, Inc.
K623-317
In Commercial Distribution

  • 00766588233178 ()
K623-317

  • First aid kit, medicated
36M - PG&E Class B 21
Certified Safety Manufacturing, Inc.
K623-305
In Commercial Distribution

  • 00766588233055 ()
K623-305

  • First aid kit, medicated
16PW - PG&E Class A 21
Certified Safety Manufacturing, Inc.
K623-304
In Commercial Distribution

  • 00766588233048 ()
K623-304

  • First aid kit, medicated
CUSTOM PACK HY8V48R8 FRN HRT E
MEDTRONIC, INC.
HY8V48R8
In Commercial Distribution

  • 00763000835279 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11U53R E HEART L
MEDTRONIC, INC.
BB11U53R
In Commercial Distribution

  • 00763000618735 ()


  • Cardiopulmonary bypass system blood tubing set
Endo-Express E Type 4-Hole Air Motor
ESSENTIAL DENTAL SYSTEMS, INC.
5510-00
Not in Commercial Distribution

  • 00766054001201 ()
5510-00

  • Dental power tool handpiece motorless component
D AND E 2ND TRIMESTER PACK
MEDLINE INDUSTRIES, INC.
DYNJ82171A
In Commercial Distribution

  • 40195327518807 ()
  • 10195327518806 ()
DYNJ82171A

  • General surgical procedure kit, non-medicated, single-use
e360 Ventilator with Accessories;E Model
Covidien LP
E360P-SY-NA
Not in Commercial Distribution

  • 10884521541047 ()
E360P-SY-NA

  • Neonatal/adult intensive-care ventilator
CUSTOM PACK BB1B37R38 E WO R
MEDTRONIC, INC.
BB1B37R38
In Commercial Distribution

  • 00199150021697 ()


  • Cardiopulmonary bypass system blood tubing set
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
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
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
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 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™ 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™ 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™ Enteric Pathogens Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8184
In Commercial Distribution

  • 70845357041448 ()
8184

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
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™ Enteric Parasite Verification Panel (Synthetic)
MICROBIOLOGICS INC.
8182
Not in Commercial Distribution

  • 70845357041356 ()
8182

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Viral Control Panel
MICROBIOLOGICS INC.
8211
In Commercial Distribution

  • 70845357041158 ()
8211

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Viral Verification Panel
MICROBIOLOGICS INC.
8210
In Commercial Distribution

  • 70845357041141 ()
8210

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
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 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)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
425089
In Commercial Distribution

  • 00815381020963 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424898
In Commercial Distribution

  • 00815381020888 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0104
In Commercial Distribution

  • 00815381020116 ()
RFIT-ASY-0104

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0116
In Commercial Distribution

  • 00815381020109 ()
RFIT-ASY-0116

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
LUMINEX CORPORATION
30-002-022
In Commercial Distribution

30-002-022

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
LUMINEX CORPORATION
20-011-022
In Commercial Distribution

20-011-022

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
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