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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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Blood Pressure Long-Term Ambulatory Recorder
SPACELABS HEALTHCARE (WASHINGTON), INC
90207
Not in Commercial Distribution

  • 10841522106675 ()
N/A

  • Blood pressure ambulatory recorder
LDWR,SET,DIN,SNAP,5-LEAD,102CM/40IN,AAMI,1/ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90470
Not in Commercial Distribution

  • 10841522106590 ()
012-0285-02

  • Electrocardiographic lead set, reusable
Ambulatory Blood Pressure (ABP) Report Management System
SPACELABS HEALTHCARE (WASHINGTON), INC
92506
Not in Commercial Distribution

  • 10841522106453 ()
N/A

  • Cardiology information system application software
KIT,START-UP,5-L ECG IEC,NIBP,SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104954 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical
BP CUFF,TL NEO NON-PVC,1T,SZ 5,8-15CM,M316
Statcorp Medical
STATCORP
In Commercial Distribution

  • 30841522104774 ()
  • 10841522104770 ()
N/A

  • Blood pressure cuff, single-use
BP CUFF,TL NEO NON-PVC,1T,SZ 3,6-11CM,M316
Statcorp Medical
STATCORP
In Commercial Distribution

  • 30841522104750 ()
  • 10841522104756 ()
N/A

  • Blood pressure cuff, single-use
BP CUFF,TL NYLON,1T,SMALL ADULT,18-26CM,HP,EA
Statcorp Medical
STATCORP
In Commercial Distribution

  • 10841522104442 ()
715-1131-10

  • Blood pressure cuff, reusable
CABLE,SPO2,MASIMO SET,LN CS
SPACELABS HEALTHCARE (WASHINGTON), INC
91496
Not in Commercial Distribution

  • 10841522103841 ()
700-0906-01

  • Electrical-only medical device connection cable, reusable
CABLE,SPO2,NELLCOR,OXIMA X
SPACELABS HEALTHCARE (WASHINGTON), INC
91496
Not in Commercial Distribution

  • 10841522103834 ()
700-0792-00

  • Electrical-only medical device connection cable, reusable
CABLE,PX,LCF,3SNAPS,CLIP,RD/YL/GN,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
700-0317-00
Not in Commercial Distribution

  • 10841522103810 ()
700-0317-00

  • Electrical-only medical device connection cable, reusable
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