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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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bFed Refill kit containing 10 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 4 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 7 375 mL Bolee™ Bags
U DELIVER MEDICAL L.L.C.
SK-2002
In Commercial Distribution

  • 00867622000456 ()
  • 00867622000470 ()
SK-2002

  • Enteral feeding kit, adult/paediatric, non-sterile
bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 2 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 3 375 mL Bolee™ Bags
U DELIVER MEDICAL L.L.C.
SK-2001
In Commercial Distribution

  • 00867622000449 ()
  • 00867622000463 ()
SK-2001

  • Enteral feeding kit, adult/paediatric, non-sterile
NeoConnect NeoSecure Tip Cap, Sterile, Purple
NEOMED, INC.
PNM-TCNC
In Commercial Distribution

  • 20817584010967 ()
  • 10817584010960 ()
  • 00817584010963 ()
PNM-TCNC

  • Syringe tip cap
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5BC-DXXXB
In Commercial Distribution

  • 00817655022468 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
  • Electrocardiograph, professional, multichannel
  • Cardiac stress exercise monitoring system
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5AC-XXXXX
In Commercial Distribution

  • 00817655022437 ()


  • Cardiac stress exercise monitoring system
  • Electrocardiograph, professional, multichannel
  • Electrocardiographic long-term ambulatory recording analyser application software
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5AC-XXXXA
In Commercial Distribution

  • 00817655022413 ()


  • Cardiac stress exercise monitoring system
  • Electrocardiograph, professional, multichannel
  • Electrocardiographic long-term ambulatory recording analyser application software
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5AC-DXXXB
In Commercial Distribution

  • 00817655022390 ()


  • Cardiac stress exercise monitoring system
  • Electrocardiograph, professional, multichannel
  • Electrocardiographic long-term ambulatory recording analyser application software
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5AC-DXXXA
In Commercial Distribution

  • 00817655022383 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
  • Electrocardiograph, professional, multichannel
  • Cardiac stress exercise monitoring system
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5AC-CXXXX
In Commercial Distribution

  • 00817655022376 ()


  • Cardiac stress exercise monitoring system
  • Electrocardiograph, professional, multichannel
  • Electrocardiographic long-term ambulatory recording analyser application software
Cardiology Information System Workstation
MORTARA INSTRUMENT, INC.
MDLTYMGR-5AC-CXXXA
In Commercial Distribution

  • 00817655022369 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
  • Electrocardiograph, professional, multichannel
  • Cardiac stress exercise monitoring system
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