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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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PROPAQ MD, 12LD, SPO2, CO2, NIBP, IBP, TEMP, 1 BATTERY, US MILITARY, REFURB
Zoll Medical Corporation
301-1011301-01-66
In Commercial Distribution

  • 00847946081089 ()


  • Rechargeable professional automated external defibrillator
PROPAQ MD, 12LD, SPO2, CO2, NIBP, IBP, TEMP, 1 BATTERY, US MILITARY
Zoll Medical Corporation
301-1011301-01
In Commercial Distribution

  • 00847946081072 ()


  • Rechargeable professional automated external defibrillator
X SERIES, ALS, 12 LD, PACE, NELLCOR, SPO2, SPCO, SPMET, ETCO2, IBP/TEMP, NIBP, CPR EXTENDED, DMST
Zoll Medical Corporation
601-2281511-01
In Commercial Distribution

  • 00847946062712 ()


  • Rechargeable professional automated external defibrillator
X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPHB, SPOC, SPCO ,SPMET, PVI & PI,(RAINBOW), IBP/TEMP CPR EXPANSION PACK AND ETCO2.,DMST, REFURB
Zoll Medical Corporation
601-2271511-01-66
In Commercial Distribution

  • 00847946062675 ()


  • Rechargeable professional automated external defibrillator
X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2, SPCO, SPMET, SPHB, SPOC PVI & PI, BVM/TEMP, CPR EXTENDED INSTALLED, REMOTE VIEW, US
Zoll Medical Corporation
601-2271212-01
In Commercial Distribution

  • 00847946062651 ()


  • Rechargeable professional automated external defibrillator
X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12-LEAD W/INTERP, PACE, SPO2, SPCO, SPMET, SPHB, SPOC, PVI, PI, ETCO2 BVM, NIBP, CPR EXPANSION PACK, US
Zoll Medical Corporation
601-2271111-01
In Commercial Distribution

  • 00847946062620 ()


  • Rechargeable professional automated external defibrillator
X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPHB, SPOC, SPCO ,SPMET, PVI & PI,(RAINBOW), CPR EXPANSION PACK AND ETCO2.,DMST
Zoll Medical Corporation
601-2271011-01
In Commercial Distribution

  • 00847946062613 ()


  • Rechargeable professional automated external defibrillator
sPS Third Generation PSA Control Module
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10708295
In Commercial Distribution

  • 00630414982281 ()
  • 00630414601793 ()
LUPCM(D)

  • Total prostate specific antigen (tPSA) IVD, control
The Cross-Seal Accessories (Cross-Seal Knot Tyer, Cross-Seal Knot Pusher, and Cross-Seal Suture Trimmer) are designed to tie the knots, position the knot to the top of the arteriotomy, and to trim the trailing limbs of the suture, respectively.
MEDEON BIODESIGN, INC.
002
In Commercial Distribution

  • 04719872920380 ()
  • 04719872920397 ()
  • 04719872920403 ()
002

  • Polyolefin/fluoropolymer suture, monofilament
The Cross-Seal Device is composed of a Catheter, Suture Delivery System, and Handle. The Cross-Seal Device tracks over a standard 0.038” or 0.035” (minimum length 130 cm) guidewire. A hemostasis valve located in the middle of the CATHETER limits blood flow from the GUIDEWIRE PORT through the CATHETER with or without the guidewire in place. The SUTURE DELIVERY SYSTEM contains NEEDLES, LOCATOR WINGS, and the NEEDLE BARREL that control suture placement around the arteriotomy. The HANDLE contains the SLIDER, BLEEDING INDICATOR, PLUNGER, RESET 1 BUTTON (SLIDER RETRACTOR), and RESET 2 BUTTON (LOCATOR WINGS RETRACTOR). The SLIDER triggers a mechanism that opens the LOCATOR WINGS and creates a sandwich configuration to stabilize the delivery system within the vessel wall. The BLEEDING INDICATOR connects to a lumen that has an intraluminal port positioned at the distal end of the Suture Delivery System to allow bleeding back to ensure Suture Delivery System is positioned properly in the femoral artery. The NEEDLE BARREL keeps the Cross-Seal Device from moving deeper inside the vessel, stabilizes the device once the LOCATOR WINGS are opened and retrieves the disengaged suture-carried NEEDLES. The PLUNGER triggers the NEEDLES to deploy sutures and simultaneously close the LOCATOR WINGS. The GUIDEWIRE GUIDE is the feature at distal handle portion which allows physician to practice coaxial insertion of device along guidewire if necessary.
MEDEON BIODESIGN, INC.
002
In Commercial Distribution

  • 04719872920359 ()
  • 04719872920366 ()
  • 04719872920373 ()
002

  • Polyolefin/fluoropolymer suture, monofilament
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