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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LDWR,SET,SHLD,PNCH,10-LD,102CM/40IN,AAMI,1/ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90496
Not in Commercial Distribution

  • 10841522110399 ()
N/A

  • Electrocardiographic lead set, reusable
PATIENT FLOW SENSOR - SINGLE UNIT
SPACELABS HEALTHCARE (WASHINGTON), INC
6500V; 8500V
Not in Commercial Distribution

  • 10841522109836 ()
10110090

  • Breathing circuit gas-flow sensor, 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
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
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

  • 10841522106453 ()
N/A

  • Cardiology information system application software
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,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
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 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 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 3,6-11CM,M316
Statcorp Medical
STATCORP
In Commercial Distribution

  • 30841522104750 ()
  • 10841522104756 ()
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
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
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,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,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
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
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

  • 10841522103599 ()
  • 00841522103592 ()


  • 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

  • 10841522103315 ()
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
BATTERY,LITHIUM, FOR SL6 / SL6A
SPACELABS HEALTHCARE (WASHINGTON), INC
98400
Not in Commercial Distribution

  • 10841522103292 ()
N/A

  • Portable/mobile rechargeable battery pack
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 (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103131 ()
040-1713-00

  • Cardiology information system application software
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 (X5) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103117 ()
040-1711-00

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

  • 10841522103094 ()
040-1709-00

  • Cardiology information system application software
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
KIT, DM3 UPDATE, V1.8
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102981 ()
V1.8

  • Multiple vital physiological parameter monitoring system, clinical
KIT, DM3 UPDATE, V1.7
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102974 ()
V1.7

  • Multiple vital physiological parameter monitoring system, clinical
FIELD UPGRADE ABSORBER LOCK
SPACELABS HEALTHCARE (WASHINGTON), INC
SIRIUS
Not in Commercial Distribution

  • 10841522102967 ()
N/A

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

  • 10841522102844 ()
3.05.07EN

  • Electrocardiography monitoring system receiver
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
KIT,TM MOD,MV1 TO MV2
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102813 ()
3.05.07EN

  • Electrocardiography monitoring system receiver
KIT,TM MOD,MV1 TO MV1 ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102806 ()
3.05.07EN

  • Electrocardiography monitoring system receiver
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
KIT,TM MOD,MV0 TO MV2 ST
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102752 ()
3.05.07EN

  • Electrocardiography monitoring system receiver
KIT,TM MOD,MV0 TO MV2
SPACELABS HEALTHCARE (WASHINGTON), INC
90478
Not in Commercial Distribution

  • 10841522102745 ()
3.05.05EN

  • Electrocardiography monitoring system receiver
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