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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 - 10841522103292

BATTERY,LITHIUM, FOR SL6 / SL6A
SPACELABS HEALTHCARE (WASHINGTON), INC
98400
Not in Commercial Distribution

  • 10841522103292 ()
N/A

  • Portable/mobile rechargeable battery pack

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

PathfinderSL - 10841522103131

SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103131 ()
040-1713-00

  • Cardiology information system application software

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 - 10841522103117

SENTINEL 10 WORKSTATION (X5) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103117 ()
040-1711-00

  • Cardiology information system application software

Sentinel - 10841522103100

SENTINEL 10 WORKSTATION (X2) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103100 ()
040-1710-00

  • 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

PathfinderSL - 10841522103087

SENTINEL 10 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522103087 ()
040-1708-00

  • Electrocardiographic long-term ambulatory recording analyser

UltraviewSL - 10841522102981

KIT, DM3 UPDATE, V1.8
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102981 ()
V1.8

  • Multiple vital physiological parameter monitoring system, clinical

UltraviewSL - 10841522102974

KIT, DM3 UPDATE, V1.7
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102974 ()
V1.7

  • Multiple vital physiological parameter monitoring system, clinical

Blease - 10841522102967

FIELD UPGRADE ABSORBER LOCK
SPACELABS HEALTHCARE (WASHINGTON), INC
SIRIUS
Not in Commercial Distribution

  • 10841522102967 ()
N/A

  • Anaesthesia unit, mobile

Spacelabs Healthcare - 10841522102868

KIT, MULTI-BAND, W/PS, PLEN, ACT ANT,ADC
SPACELABS HEALTHCARE (WASHINGTON), INC
96280
In Commercial Distribution

  • 10841522102868 ()
040-1428-03

  • Electrocardiography monitoring system receiver

Ultraview - 10841522102844

KIT,TM MOD,MV2 TO MV2 ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102844 ()
3.05.07EN

  • Electrocardiography monitoring system receiver

Ultraview - 10841522102837

KIT,TM MOD,MV1 ST TO MV2 ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102837 ()
3.05.07EN

  • Electrocardiography monitoring system receiver

Ultraview - 10841522102813

KIT,TM MOD,MV1 TO MV2
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102813 ()
3.05.07EN

  • Electrocardiography monitoring system receiver

Ultraview - 10841522102806

KIT,TM MOD,MV1 TO MV1 ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102806 ()
3.05.07EN

  • Electrocardiography monitoring system receiver

Ultraview - 10841522102790

KIT,TM MOD,MV0 ST TO MV2 ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102790 ()
3.05.07EN

  • Electrocardiography monitoring system receiver

Ultraview - 10841522102752

KIT,TM MOD,MV0 TO MV2 ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102752 ()
3.05.07EN

  • Electrocardiography monitoring system receiver

Ultraview - 10841522102745

KIT,TM MOD,MV0 TO MV2
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102745 ()
3.05.05EN

  • Electrocardiography monitoring system receiver

Spacelabs Healthcare - 10841522102738

KIT,DUAL-ANT,UHF,ACT,W/PS,PLEN,INTL,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
96280
Not in Commercial Distribution

  • 10841522102738 ()
040-0525-01

  • Electrocardiography monitoring system receiver

Spacelabs Healthcare - 10841522102721

KIT,DUAL-ANT,UHF,ACT,W/PS,INTL,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
96280
Not in Commercial Distribution

  • 10841522102721 ()
040-0522-01

  • Electrocardiography monitoring system receiver

XTR - 10841522102714

16 Patient Telemetry Receiver
SPACELABS HEALTHCARE (WASHINGTON), INC
96280
In Commercial Distribution

  • 10841522102714 ()
N/A

  • Electrocardiography monitoring system receiver

XTR - 10841522102707

16 Patient Telemetry Receiver
SPACELABS HEALTHCARE (WASHINGTON), INC
96280
In Commercial Distribution

  • 10841522102707 ()
N/A

  • Electrocardiography monitoring system receiver

Spacelabs Healthcare - 10841522102691

KIT,DUAL ANT,ACTIVE,W/PS,UHF,HI LVL,ROHS
SPACELABS HEALTHCARE (WASHINGTON), INC
96280
Not in Commercial Distribution

  • 10841522102691 ()
040-0387-01

  • Electrocardiography monitoring system receiver

Trulink - 10841522102509

ELECTRODE,NEONATAL,PRE-WIRED,POUCH,3/ST
SPACELABS HEALTHCARE (WASHINGTON), INC
NEO ELECTRODES
In Commercial Distribution

  • 30841522102503 ()
  • 10841522102509 ()
015-0244-00

  • Electrocardiographic electrode, single-use

TruLink - 10841522102271

SENSOR,SPO2,UNIVERSAL,DIXTAL
SPACELABS HEALTHCARE (WASHINGTON), INC
015-0133-01
Not in Commercial Distribution

  • 10841522102271 ()


  • Pulse oximeter probe, reusable

Trulink - 10841522102219

LDWR,INDV,SHLD,SNAP,BLACK,102CM/40IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522102219 ()
  • 00841522102212 ()
012-0698-09

  • Electrocardiographic lead set, reusable

Trulink - 10841522102202

LDWR,INDV,SHLD,SNAP,WHITE,102CM/40IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522102202 ()
  • 00841522102205 ()
012-0698-08

  • Electrocardiographic lead set, reusable

Trulink - 10841522102196

LDWR,INDV,SHLD,SNAP,GREEN,102CM/40IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522102196 ()
  • 00841522102199 ()
012-0698-07

  • Electrocardiographic lead set, reusable

Trulink - 10841522102189

LDWR,INDV,SHLD,SNAP,RED,102CM/40IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522102189 ()
  • 00841522102182 ()
012-0698-06

  • Electrocardiographic lead set, reusable

Trulink - 10841522102172

LDWR,INDV,SHLD,SNAP,BLACK,61CM/24IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522102172 ()
  • 00841522102175 ()
012-0698-04

  • Electrocardiographic lead set, reusable

Trulink - 10841522102165

LDWR,INDV,SHLD,SNAP,WHITE,61CM/24IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522102165 ()
  • 00841522102168 ()
012-0698-03

  • Electrocardiographic lead set, reusable

Trulink - 10841522102158

LDWR,INDV,SHLD,SNAP,GREEN,61CM/24IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522102158 ()
  • 00841522102151 ()
012-0698-01

  • Electrocardiographic lead set, reusable

Trulink - 10841522102141

LDWR,INDV,SHLD,SNAP,RED,61CM/24IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
In Commercial Distribution

  • 10841522102141 ()
  • 00841522102144 ()
012-0698-00

  • Electrocardiographic lead set, reusable

Trulink - 10841522102110

LDWR,INDV,SHLD,SNAP,BLACK,61CM/24IN,AAMI,5/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
SUPPLY
Not in Commercial Distribution

  • 10841522102110 ()
  • 00841522102113 ()
012-0498-34

  • Electrocardiographic lead set, reusable

Trulink - 10841522102097

LDWR,INDV,SHLD,SNAP,YELLOW,102CM/40IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
90492
In Commercial Distribution

  • 10841522102097 ()
  • 00841522102090 ()
012-0498-26

  • Electrocardiographic lead set, reusable

Trulink - 10841522102080

LDWR,INDV,SHLD,SNAP,VLT/WHT,61CM/24IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
90492
In Commercial Distribution

  • 10841522102080 ()
  • 00841522102083 ()
012-0498-25

  • Electrocardiographic lead set, reusable

Trulink - 10841522102073

LDWR,INDV,SHLD,SNAP,BLK/WHT,61CM/24IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
90492
In Commercial Distribution

  • 10841522102073 ()
  • 00841522102076 ()
012-0498-24

  • Electrocardiographic lead set, reusable

Trulink - 10841522102066

LDWR,INDV,SHLD,SNAP,GRN/WHT,61CM/24IN,IEC,3/PK
SPACELABS HEALTHCARE (WASHINGTON), INC
90492
Not in Commercial Distribution

  • 10841522102066 ()
  • 00841522102069 ()
012-0498-22

  • Electrocardiographic lead set, reusable
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