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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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SPACELABS HEALTHCARE - 10841522123061

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

SPACELABS HEALTHCARE - 10841522122811

PEDIATRIC FLOW SENSOR SINGLE ITEM KIT
SPACELABS HEALTHCARE (WASHINGTON), INC
700900V
In Commercial Distribution

  • 10841522122811 ()
376-0561-01

  • Breathing circuit gas-flow sensor, reusable

Trulink - 10841522122798

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

Trulink - 10841522122774

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

Trulink - 10841522122750

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

Trulink - 10841522122736

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

SPACELABS HEALTHCARE - 10841522122712

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

Trulink - 10841522122699

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

SPACELABS HEALTHCARE - 10841522122668

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

SPACELABS HEALTHCARE - 10841522122644

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

ULTRAVIEW SL - 10841522122620

CABLE ASSEMBLY,SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
Not in Commercial Distribution

  • 10841522122620 ()
175-0646-00

  • Pulse oximeter probe, reusable

SPACELABS HEALTHCARE - 10841522122514

FETAL,CABLE,PATIENT
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522122514 ()
700-0020-01

  • Electrical-only medical device connection cable, reusable

Spacelabs Healthcare - 10841522122088

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

Spacelabs Healthcare - 10841522122033

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

Spacelabs Healthcare - 10841522120206

KIT,DUAL ANTENNA,PASSIVE,UHF,PLENUM,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
96280
Not in Commercial Distribution

  • 10841522120206 ()
040-0441-02

  • Electrocardiography monitoring system receiver

Trulink - 10841522113024

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

SPACELABS HEALTHCARE - 10841522111914

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

SPACELABS HEALTHCARE - 10841522111884

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

SPACELABS HEALTHCARE - 10841522111846

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

SPACELABS HEALTHCARE - 10841522111822

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

SPACELABS HEALTHCARE - 10841522111815

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

SPACELABS HEALTHCARE - 10841522111792

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

SPACELABS HEALTHCARE - 10841522111785

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

SPACELABS HEALTHCARE - 10841522111761

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

SPACELABS HEALTHCARE - 10841522111754

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

SPACELABS HEALTHCARE - 10841522111730

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

Trulink - 10841522111037

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

Trulink - 10841522111013

Supplies and Accessories
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522111013 ()
  • 00841522111016 ()
N/A

  • Electrocardiographic lead set, reusable

Trulink - 10841522110993

Supplies and Accessories
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522110993 ()
  • 00841522110996 ()
N/A

  • Electrocardiographic lead set, reusable

Trulink - 10841522110894

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

Spacelabs Healthcare - 10841522109676

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

Sentinel - 10841522106521

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

ABP - 10841522106446

Ambulatory Blood Pressure (ABP) Report Management System
SPACELABS HEALTHCARE (WASHINGTON), INC
92506
Not in Commercial Distribution

  • 10841522106446 ()
N/A

  • Cardiology information system application software

Spacelabs Healthcare - 10841522104985

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

Spacelabs Healthcare - 10841522104947

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

Spacelabs Healthcare - 10841522104930

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

Statcorp Medical - 10841522104763

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

Statcorp Medical - 10841522104749

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

Statcorp Medical - 10841522104732

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

STATCORP MEDICAL - 10841522103957

ABP CUFF,SPACELABS,1T,SMALL ADULT,SINGLE
SPACELABS HEALTHCARE (WASHINGTON), INC
STATCORP
Not in Commercial Distribution

  • 30841522103951 ()
  • 10841522103957 ()
015-1826

  • Blood pressure cuff, reusable

Spacelabs Healthcare - 10841522103827

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

Trulink - 10841522103605

Supplies and Accessories
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522103605 ()
  • 00841522103608 ()


  • Electrocardiographic lead set, reusable

Trulink - 10841522103582

Supplies and Accessories
SPACELABS HEALTHCARE (WASHINGTON), INC
AMC
Not in Commercial Distribution

  • 10841522103582 ()
  • 00841522103585 ()


  • Electrocardiographic lead set, reusable

Sentinel - 10841522103452

Cardiology Information Management System
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103452 ()
10.0.1

  • Cardiac stress exercise monitoring system

Spacelabs Healthcare - 10841522103322

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

  • 10841522103322 ()
N/A

  • Electrocardiographic lead set, reusable

Spacelabs Healthcare - 10841522103308

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

  • 10841522103308 ()
N/A

  • Electrocardiographic lead set, reusable

PathfinderSL; SENTINEL - 10841522103209

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

PATHFINDER SL, SENTINEL10 - 10841522103193

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 - 10841522103124

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 - 10841522103094

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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