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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VARIOS YOKE WITH 700-0331-00 LONG CABLE AHA,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF; LCF_CBL; PXCABLES
Not in Commercial Distribution

  • 10841522123061 ()
700-0365-00

  • Electrical-only medical device connection cable, reusable
PEDIATRIC FLOW SENSOR SINGLE ITEM KIT
SPACELABS HEALTHCARE (WASHINGTON), INC
700900V
In Commercial Distribution

  • 10841522122811 ()
376-0561-01

  • Breathing circuit gas-flow sensor, reusable
LDWR SET,SNAP,ECG,127CM/50IN,AAMI,5LW/SET,BX/25
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522122798 ()
700-0007-32

  • Electrocardiographic lead set, reusable
LDWR SET,SNAP,ECG,127CM/50 IN,3LW/SET,BX/25
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522122774 ()
700-0007-30

  • Electrocardiographic lead set, reusable
LDWR SET,V LDS,PINCH,ECG ,127CM/50IN,5LW/ST,BX/25
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
In Commercial Distribution

  • 10841522122750 ()
700-0006-33

  • Electrocardiographic lead set, reusable
LDWR SET,V LDS,PINCH,ECG,127CM/50IN,4LW/ST,BX/25
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522122736 ()
700-006-31

  • Electrocardiographic lead set, reusable
10 LD STRESS PATIENT CABLE, US
SPACELABS HEALTHCARE (WASHINGTON), INC
PXCABLES
Not in Commercial Distribution

  • 10841522122712 ()
41-0695

  • Electrical-only medical device connection cable, reusable
LDWR SET SNAP,ECG,50IN,AAMI,6LW/SET BX/25
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522122699 ()
700-0007-34

  • Electrocardiographic lead set, reusable
10 ELECTRODE PT.CABLE, SHORT.BA
SPACELABS HEALTHCARE (WASHINGTON), INC
PXCABLES
Not in Commercial Distribution

  • 10841522122668 ()
25-0027

  • Electrical-only medical device connection cable, reusable
PATIENT CABLE SINGLE CHANNEL, BLK/WHT, US CODE
SPACELABS HEALTHCARE (WASHINGTON), INC
PXCABLES
In Commercial Distribution

  • 10841522122644 ()
23-0059

  • Electrical-only medical device connection cable, reusable
CABLE ASSEMBLY,SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
Not in Commercial Distribution

  • 10841522122620 ()
175-0646-00

  • Pulse oximeter probe, reusable
FETAL,CABLE,PATIENT
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522122514 ()
700-0020-01

  • Electrical-only medical device connection cable, reusable
LDWR,SNAP,DIN,WHITE,61CM/24IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522122088 ()
012-0295-17

  • Electrocardiographic lead set, reusable
LDWR,SNAP,DIN,BLACK,61CM/24IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522122033 ()
012-0295-27

  • Electrocardiographic lead set, reusable
KIT,DUAL ANTENNA,PASSIVE,UHF,PLENUM,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
96280
Not in Commercial Distribution

  • 10841522120206 ()
040-0441-02

  • Electrocardiography monitoring system receiver
LDWR,INDV,DIN,PINCH,WHITE,46CM/18IN,AAMI,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
90470
Not in Commercial Distribution

  • 10841522113024 ()
  • 00841522113027 ()
012-0296-10

  • Electrocardiographic lead set, reusable
CABLE,PATIENT,LC12,LONG,DEFIB PROTECT,US CODE
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF, LCF_CBL, PXCABLES
Not in Commercial Distribution

  • 10841522111914 ()
700-0331-00

  • Electrical-only medical device connection cable, reusable
LC12 PATIENT CABLE US DEFIB PROTECTED US,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF; LCF_CBL; PXCABLES
Not in Commercial Distribution

  • 10841522111884 ()
700-0329-00

  • Electrical-only medical device connection cable, reusable
LC12 VARIOS YOKE ASSEMBLY,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF; LCF_CBL; PXCABLES
Not in Commercial Distribution

  • 10841522111846 ()
700-0325-00

  • Electrical-only medical device connection cable, reusable
CABLE,PX,LCF,4SNAP,SHRT,WO/CLIP,RD/WH/BN/BK,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
700-0324-00
Not in Commercial Distribution

  • 10841522111822 ()
700-0324-00

  • Electrical-only medical device connection cable, reusable
CABLE,PX,LCF,4SNAPS,CLIP,RD/WH/BN/BK,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
700-0323-00
Not in Commercial Distribution

  • 10841522111815 ()
700-0323-00

  • Electrical-only medical device connection cable, reusable
CABLE,PX,LCF,7RECEPTACLE,AHA,WO/LEADWIRES,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
700-0322-00
Not in Commercial Distribution

  • 10841522111792 ()
700-0322-00

  • Electrical-only medical device connection cable, reusable
CABLE,PX,LCF,2SNAP,SHORT,WO/CLIP,RD/WH.ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
700-0321-00
Not in Commercial Distribution

  • 10841522111785 ()
700-0321-00

  • Electrical-only medical device connection cable, reusable
CABLE,PX,LCF,2SNAP,CLIP,RD/WH.ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
700-0320-00
Not in Commercial Distribution

  • 10841522111761 ()
700-0320-00

  • Electrical-only medical device connection cable, reusable
CABLE,PX,LCF,3SNAPS,CLIP,RD/YL/GN,X-LONG,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
700-0318-00
Not in Commercial Distribution

  • 10841522111754 ()
700-0318-00

  • Electrical-only medical device connection cable, reusable
CABLE,PX,LCF,6RECEPTACLE,AHA,WO/LEADWIRES,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
700-0316-00
Not in Commercial Distribution

  • 10841522111730 ()
700-0316-00

  • Electrical-only medical device connection cable, reusable
LDWR SET,V LDS,SNAP,ECG,74CM/29IN,4LW/SET,1/SET
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522111037 ()
700-0007-36

  • Electrocardiographic lead set, reusable
Supplies and Accessories
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522111013 ()
  • 00841522111016 ()
N/A

  • Electrocardiographic lead set, reusable
Supplies and Accessories
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522110993 ()
  • 00841522110996 ()
N/A

  • Electrocardiographic lead set, reusable
LDWR SET,PINCH,ECG,29IN,AAMI,6LW/SET,1/SET
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522110894 ()
700-0006-39

  • Electrocardiographic lead set, reusable
LDWR,SNAP,SHIELD,BLACK,102CM/40IN,AAMI,5/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
Not in Commercial Distribution

  • 10841522109676 ()
  • 00841522109679 ()
N/A

  • Electrocardiographic lead set, reusable
PATHFINDER SL HOLTER ANALYSER (ENGLISH) KIT
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522106521 ()
98000-01 KIT

  • Electrocardiographic long-term ambulatory recording analyser
Ambulatory Blood Pressure (ABP) Report Management System
SPACELABS HEALTHCARE (WASHINGTON), INC
92506
Not in Commercial Distribution

  • 10841522106446 ()
N/A

  • Cardiology information system application software
KIT,START-UP,3-L ECG IEC,NIBP,SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104985 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical
KIT,START UP KIT UPGRADE,SKIN TEMP SENSOR
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104947 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical
KIT,START UP KIT UPGRADE,5-L ECG AAMI
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104930 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical
BP CUFF,TL NEO NON-PVC,1T,SZ 4,7-13CM,M316
Statcorp Medical
STATCORP
In Commercial Distribution

  • 30841522104767 ()
  • 10841522104763 ()
N/A

  • Blood pressure cuff, single-use
BP CUFF,TL NEO NON-PVC,1T,SZ 2,4-8CM,M316
Statcorp Medical
STATCORP
In Commercial Distribution

  • 10841522104749 ()
  • 30841522104743 ()
715-2124-00

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

  • 30841522104736 ()
  • 10841522104732 ()
N/A

  • Blood pressure cuff, single-use
ABP CUFF,SPACELABS,1T,SMALL ADULT,SINGLE
SPACELABS HEALTHCARE (WASHINGTON), INC
STATCORP
Not in Commercial Distribution

  • 30841522103951 ()
  • 10841522103957 ()
015-1826

  • Blood pressure cuff, reusable
CABLE,PX,LCF,3SNAP,SHORT,WO/CLIP,RD/YL/GN,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
700-0319-00
Not in Commercial Distribution

  • 10841522103827 ()
700-0319-00

  • Electrical-only medical device connection cable, reusable
Supplies and Accessories
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522103605 ()
  • 00841522103608 ()


  • Electrocardiographic lead set, reusable
Supplies and Accessories
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522103582 ()
  • 00841522103585 ()


  • Electrocardiographic lead set, reusable
Cardiology Information Management System
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103452 ()
10.0.1

  • Cardiac stress exercise monitoring system
Evo Holter Recorder, originally Del Mar Reynolds product
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522103322 ()
N/A

  • Electrocardiographic lead set, reusable
Evo Holter Recorder, originally Del Mar Reynolds product
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522103308 ()
N/A

  • Electrocardiographic lead set, reusable
UPGRADE: CNAV+ TO PATHFINDER SL, SENTINEL10
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200; NAVPLUS
Not in Commercial Distribution

  • 10841522103209 ()
043-0129-00

  • Electrocardiographic long-term ambulatory recording analyser
UPGRADE: PA-DIGITAL TO PATHFINDER SL, SENTINEL10
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200, PATHFIND
Not in Commercial Distribution

  • 10841522103193 ()
043-0128-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 WORKSTATION (X10) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103124 ()
040-1712-00

  • Cardiology information system application software
SENTINEL 10 WORKSTATION (X1) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103094 ()
040-1709-00

  • Cardiology information system application software
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