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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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AeroSled Transport Deck (TD) - 00810050861847

AEROSLED, MACHINED, TD, 16G WITH LIMITATION PLACARD * TRANSPORT DECK
LIFEPORT, LLC
AS1-062-01
In Commercial Distribution

  • 00810050861847 ()


  • Desk mount

AeroSled Transport Deck (TD) - 00810050861519

AEROSLED TD (200 LB) * TRANSPORT DECK, RED
LIFEPORT, LLC
AS1-003-01
In Commercial Distribution

  • 00810050861519 ()


  • Desk mount

AeroSled Transport Deck (TD) - 00810050861434

ASSEMBLY, AEROSLED TD
LIFEPORT, LLC
AS1-059-03
In Commercial Distribution

  • 00810050861434 ()


  • Desk mount

AeroSled Transport Deck (TD) - 00810050861427

ASSEMBLY, AEROSLED TD
LIFEPORT, LLC
AS1-059-01
In Commercial Distribution

  • 00810050861427 ()


  • Desk mount

AeroSled Transport Deck (TD) - 00810050861373

ASSEMBLY, AEROSLED TD
LIFEPORT, LLC
AS1-059-05
In Commercial Distribution

  • 00810050861373 ()


  • Desk mount

aprevo - 00810056991302

aprevo® Awl
Carlsmed, Inc.
1080
In Commercial Distribution

  • 00810056991302 ()


  • Internal spinal fixation procedure kit, single-use

AO INSERTER SHAFT (80MM) - 00887868091636

No Description
Biomet Orthopedics, LLC
14-401424
In Commercial Distribution

  • 00887868091636 ()
14-401424

  • Orthopaedic inorganic implant inserter/extractor, reusable

Curaplex - 00812277035407

*Custom* Lucas County Igel size 5
BOUND TREE MEDICAL, LLC
8600-01408
In Commercial Distribution

  • 00812277035407 ()
8600-01408

  • Laryngeal mask airway, single-use
  • Airway suction catheter

Curaplex - 00812277035391

*Custom* Lucas County Igel size 4
BOUND TREE MEDICAL, LLC
8600-01407
In Commercial Distribution

  • 00812277035391 ()
  • 00810094573256 ()
8600-01407

  • Airway suction catheter
  • Laryngeal mask airway, single-use

Curaplex - 00812277035384

*Custom* Lucas County Igel size 3
BOUND TREE MEDICAL, LLC
8600-01406
In Commercial Distribution

  • 00812277035384 ()
  • 00810094573249 ()
8600-01406

  • Laryngeal mask airway, single-use
  • Airway suction catheter

Curaplex - 00812277033809

*Custom* BlueSensor ECG Kit w/ Benzoin & Razor
BOUND TREE MEDICAL, LLC
8600-01370
In Commercial Distribution

  • 00812277033809 ()
  • 00810094572983 ()
8600-01370

  • Electrode conductive skin pad, single-use

Audit MicroControls Method Val FD GFAP for bioMérieux VIDAS® TBI (GFAP) - B085K853M200

No Description
AALTO SCIENTIFIC
K853M-20
In Commercial Distribution

  • B085K853M200 ()


  • Multiple traumatic brain injury marker IVD, control

Audit MicroControls Method Val FD UCH-L1 for bioMérieux VIDAS® TBI (UCH-L1) - B085K852M200

No Description
AALTO SCIENTIFIC
K852M-20
In Commercial Distribution

  • B085K852M200 ()


  • Multiple traumatic brain injury marker IVD, control

Audit MicroControls Linearity FD Traumatic Brain Injury (TBI) - B085K739M100

No Description
AALTO SCIENTIFIC
K739M-10
In Commercial Distribution

  • B085K739M100 ()


  • Multiple traumatic brain injury marker IVD, control

Audit MicroControls Linearity FD BNP (Extended) - B085K737M50

No Description
AALTO SCIENTIFIC
K737M-5
In Commercial Distribution

  • B085K737M50 ()


  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Audit MicroControls Linearity FD BNP (High) - B085K713M50

No Description
AALTO SCIENTIFIC
K713M-5
In Commercial Distribution

  • B085K713M50 ()


  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Audit MicroControls Linearity FD BNP (Low) - B085K708M50

No Description
AALTO SCIENTIFIC
K708M-5
In Commercial Distribution

  • B085K708M50 ()


  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Uric Acid ver.2 - 07613336121580

No Description
Roche Diagnostics GmbH
08058750190
In Commercial Distribution

  • 07613336121580 ()
08058750190

  • Uric acid IVD, kit, spectrophotometry

LIFEPAK CR2 - 07613327681857

USED LPCR2,WIFI,B,EN-US,ES-ES,S,2,ROS,MODET,ROS
PHYSIO-CONTROL, INC.
99512
In Commercial Distribution

  • 07613327681857 ()
99512-001265U

  • Non-rechargeable public semi-automated external defibrillator

LIFEPAK 15 MONITOR/DEFIBRILLATOR - 07613327666663

USED LP15,EN,SPO2,3L,EX,CO2,TR,VR,MNC,V4
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 07613327666663 ()
99577-002178U

  • Physiologic-monitoring defibrillation system

LIFEPAK 15 MONITOR/DEFIBRILLATOR - 07613327666649

USED LP15,EN,SPO2,3L,EX,CO2,TR,VR,BT,MNC,V4
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 07613327666649 ()
99577-002166U

  • Physiologic-monitoring defibrillation system

LIFEPAK 15 Monitor/Defibrillator - 07613327650839

USED LP15,EN,SPO2COMET,3L/12L,EX,NIBP,CO2,IP,TR,VR,V4
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 07613327650839 ()
99577-001937U

  • Physiologic-monitoring defibrillation system

LIFEPAK 20e Defibrillator/Monitor - 07613327650822

USED CONFIG LP20E CMM,PCNG,MNC,SPO2,ENG
PHYSIO-CONTROL, INC.
99507
In Commercial Distribution

  • 07613327650822 ()
99507-000133U

  • Physiologic-monitoring defibrillation system

LIFEPAK 20e Defibrillator/Monitor - 07613327650815

USED CONFIG LP20E CMM,PCNG,SPO2,ENG
PHYSIO-CONTROL, INC.
99507
In Commercial Distribution

  • 07613327650815 ()
99507-000132U

  • Physiologic-monitoring defibrillation system

LIFEPAK 20e Defibrillator/Monitor - 07613327650808

CONFIG LP20E CMM,PCNG,ENG USED
PHYSIO-CONTROL, INC.
99507
In Commercial Distribution

  • 07613327650808 ()
99507-000122U

  • Physiologic-monitoring defibrillation system

LIFEPAK 15 Monitor/Defibrillator - 07613327650792

USED LP15,EN,3L,EX,VR,V4
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 07613327650792 ()
99577-001930U

  • Physiologic-monitoring defibrillation system

Oral Fluid Amphetamine Enzyme Immunoassay - B076S0041B0

Large Test Kit. Antibody/Substrate Reagent (R1): 750 mL. Enzyme Conjugate Reagent (R2): 375 mL.
LIN-ZHI INTERNATIONAL, INC.
S0041b
In Commercial Distribution

  • B076S0041B0 ()
S0041b

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

Oral Fluid Amphetamine Enzyme Immunoassay - B076S0040B0

Small Test Kit. Antibody/Substrate Reagent (R1): 75 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
LIN-ZHI INTERNATIONAL, INC.
S0040b
In Commercial Distribution

  • B076S0040B0 ()
S0040b

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

DEFIB Pads - 00813150020008

Cardiac Science Adult AED Pad
GRAPHIC CONTROLS ACQUISITION CORP
D326
Not in Commercial Distribution

  • 00813150020008 ()
  • 10813150020005 ()
D326

  • Electrode conductive skin pad, single-use

Spirometry Sensor - 20884838072248

The M2786A in combination with the spirometry module M1014A is designed to allow measurement of airway pressures, flow, minute volume, tidal volume, airway compliance, airway resistance and CO2.
Philips Medizin Systeme Böblingen GmbH
Flow Sensor Neonatal
In Commercial Distribution

  • 20884838072248 ()
  • 00884838072244 ()
989803144671

  • Monitoring spirometer, electrical

NA - 20884838072088

No Description
Philips Medizin Systeme Böblingen GmbH
Airway Adapter Set - ET <=4.0 mm
Not in Commercial Distribution

  • 20884838072088 ()
989803144531

  • Nasal oxygen cannula, carbon-dioxide-sampling

HeartStart - 20884838015306

Rect. Pdl Electrode Repl. M3535A - Gray
Philips Medical Systems Hsg
Rect. Pdl Electrodes Pepl M3535A-Gray
In Commercial Distribution

  • 20884838015306 ()
M4759A

  • Rechargeable professional automated external defibrillator

NA - 20884838015283

HS Ext Sterilizable Paddles
Philips Medical Systems Hsg
989803109771
Not in Commercial Distribution

  • 20884838015283 ()
M4745A

  • Internal defibrillation electrode, adult, reusable

HeartStart - 20884838015245

External Paddles - Water Resistant
Philips Medical Systems Hsg
External Paddles Water Resistant
In Commercial Distribution

  • 20884838015245 ()
M3543A

  • External defibrillation electrode, adult, reusable

HeartStart - 20884838015207

AC Power Module
Philips Medical Systems Hsg
AC Power Module
Not in Commercial Distribution

  • 20884838015207 ()
M3539A

  • Basic power supply, reusable

NA - 20884838015184

Hands-free Cable Barrel Conn
Philips Medical Systems Hsg
Hands Free Barrel Conn
Not in Commercial Distribution

  • 20884838015184 ()
M3507A

  • Electrosurgical cable adaptor

HeartStart - 20884838015108

Replacement Pads/CPR Meter Cable
Philips Medical Systems Hsg
MRx Replacement Pads CPR Meter Cable
Not in Commercial Distribution

  • 20884838015108 ()
989803158661

  • Electrosurgical cable adaptor

NA - 20884838010646

No Description
Philips Medizin Systeme Böblingen GmbH
989803104441
In Commercial Distribution

  • 20884838010646 ()
989803104441

  • Carbon dioxide cuvette, single-use

NA - 20884838010042

No Description
Philips Medizin Systeme Böblingen GmbH
989803100331
In Commercial Distribution

  • 20884838010042 ()
989803100331

  • Microbial medical gas filter, single-use

NA - 20884838010035

No Description
Philips Medizin Systeme Böblingen GmbH
989803100311
In Commercial Distribution

  • 20884838010035 ()
989803100311

  • Gas-sampling/monitoring respiratory tubing, single-use

Kendall - 20884527020574

1510M Multi-Function Defibrillation Electrodes
Cardinal Health, Inc.
31319315
In Commercial Distribution

  • 10884527020577 ()
  • 20884527020574 ()
  • 10884521264250 ()
31319315

  • Electrode conductive skin pad, single-use

NA - 20884838002757

No Description
Philips Medical Systems Hsg
989803106981
In Commercial Distribution

  • 20884838002757 ()
989803106981

  • Electrosurgical cable adaptor

Kendall - 20884527010315

1410Z Multi-Function Defibrillation Electrodes
Cardinal Health, Inc.
31469219
Not in Commercial Distribution

  • 10884527010318 ()
  • 20884527010315 ()
  • 10884521264205 ()
31469219

  • Electrode conductive skin pad, single-use

Kendall - 20884527008435

1710H Multi-Function Defibrillation Electrodes
Cardinal Health, Inc.
40000006
Not in Commercial Distribution

  • 10884527008438 ()
  • 20884527008435 ()
  • 10884521264199 ()
40000006

  • Electrode conductive skin pad, single-use

Kendall - 20884527008428

1310P Multi-Function Defibrillation Electrodes
Cardinal Health, Inc.
31319281
Not in Commercial Distribution

  • 20884527008428 ()
  • 10884527008421 ()
  • 10884521264182 ()
31319281

  • Electrode conductive skin pad, single-use

Kendall - 20884527008411

1210H Multi-Function Defibrillation Electrodes,
Cardinal Health, Inc.
31177721
Not in Commercial Distribution

  • 20884527008411 ()
  • 30884527008418 ()
  • 10884527008414 ()
31177721

  • Electrode conductive skin pad, single-use

Trolley with pylon - 06972197480900

No Description
Hunan Vathin Medical Instrument Co., Ltd
MET-A2
In Commercial Distribution

  • 06972197480900 ()


  • Examination/operating table component trolley

Trolley - 06972197480894

No Description
Hunan Vathin Medical Instrument Co., Ltd
MET-A1
In Commercial Distribution

  • 06972197480894 ()


  • Examination/operating table component trolley

Pylon - 06972197480887

No Description
Hunan Vathin Medical Instrument Co., Ltd
ST-A1
In Commercial Distribution

  • 06972197480887 ()


  • Examination/operating table component trolley

Accent Elite System 110V (Black) - 17290110121768

No Description
ALMA LASERS LTD.
01
In Commercial Distribution

  • 17290110121768 ()


  • Radio-frequency skin/body contouring system
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