Spacelabs Healthcare N/A

GUDID 10841522100222

Remote Display Controller

SPACELABS HEALTHCARE (WASHINGTON), INC

Centralized patient monitor Centralized patient monitor
Primary Device ID10841522100222
NIH Device Record Key1a92994f-5385-4ba9-9400-b2095a6e2820
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpacelabs Healthcare
Version Model Number91388
Catalog NumberN/A
Company DUNS145581588
Company NameSPACELABS HEALTHCARE (WASHINGTON), INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522100222 [Primary]
GS110841522100222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-19
Device Publish Date2016-10-10

On-Brand Devices [Spacelabs Healthcare]

10841522126246HOLTER LEADWIRE,EVO/ARIA,WHITE.1PK
10841522126239HOLTER LEADWIRES, EVO/ARIA, BROWN. 10PK
10841522126222HOLTER LEADWIRES, EVO/ARIA, ORANGE. 10PK
10841522126215HOLTER LEADWIRES, EVO/ARIA, RED. 10PK
10841522126208HOLTER LEADWIRES, EVO/ARIA, WHITE. 10PK
10841522126192ELECTRODE SNAP LEAD SET,14" RED /WHT/ORN/BRN
10841522126185ELECTRODE SNAP LEAD SET,40" RED /WHT/ORN/BRN
10841522126178ELECTRODE SNAP LEAD SET,14"ORN/BRN/RED,7" WHT
10841522126161ELECT SNP LD SET,18" WHT/BLK/RED/GRN/ORN/BLU/BRN
10841522104534DISPLAY,19", XPREZZON,94267
10841522110795CABLE,ECG,SHLD,24 INCH,3-LEAD,305CM/10FT,IEC
10841522110757CABLE,ECG,24 INCH 3-LW,305CM/10 FT,AAMI
10841522110733CABLE,ECG,SHLD,24 INCH,5-LEAD,305CM/10FT,IEC
10841522110719CABLE,ECG,24 INCH 5-LW,305CM/10 FT,AAMI
30841522123041KIT,HOOK-UP,CASE OF 20,ARIA
30841522122860HOOK UP KIT WITH SINGLE USE POUCH, CASE OF 20
10841522109836PATIENT FLOW SENSOR - SINGLE UNIT
10841522127144LIFECARD CF DIGITAL HOLTER MON
10841522127137LIFECARD CF, 4 LEAD, HOLTER RECORDER
10841522127328KIT,UPGR,WIRELESS (OPT P),OLD 670-1712-00,91389
10841522127311KIT,UPGRADE,WIRELESS (OPT P) OLD DISPLAY,91390
10841522127304KIT,UPGRADE,WIRELESS (OPTION P),MONITORS
10841522108822CAPNO POD, 92516, REFURBISHED
108415221248844 ELECTRODE EVO, BELT MOUNTED, PACKED, FRENCH
10841522126864ABP ONTRAK MONITOR, GERMAN
10841522125416LIFECARD CF DIGITAL HOLTER MON
10841522119347DATUM+ ABBVIE INT SEVO 8% C/M QUIK-FIL - ENGLI
10841522119330DATUM+ ABBVIE QUIL-FIL SEVO 8% C/M SPANISH
10841522119316DATUM+ABBVIE 5% ISO SELECTATEC STANDARD FILL
10841522119309DATUM+ABBVIE 5% ISO CAGEMOUNT STANDARD FILLER
10841522119026DATUM+ ABBOTT INT SEVO 8% N.A.D. QUIK-FIL ENG
10841522119019DATUM+ ABBOTT INT. SEVO 8% NAD QUIK-FIL SPANISH
10841522119002DATUM+ ABBOTT 8% SEVO N.A.D. KEYFILLER
10841522118982DATUM+ ABBVIE SPAIN SEVO 8% DRAGER QUIK-FIL
10841522118975DATUM+ 8% SEVO DRAEGER QUICKFILL - MEDITEC
10841522118968DATUM+ ABBOTT SPAIN SEVO 8% DRAGER QUIK-FIL
10841522118944DATUM+ 8% SEVO DRAEGER QFILL ABBOTT AUSTRALASIA
10841522118937DATUM+ ABBOTT INT.SEVO8% DRAGER QUIK-FIL SPANISH
10841522118920DATUM+ SEVO 8% DRAGER KEYFILLER - DATUM
10841522118913DATUM+ ABBOTT 8% SEVO DRAGER KEYFILLER
10841522118906DATUM+ SEVO 8% DRAGER KEYFILLER - BLEASE
10841522118883DATUM+ SEVO8% SELECTATEC QUIK-FIL - ANMEDIC
10841522118876DATUM+ SEVO 8% TEC QUIK-FIL - MEDITEC
10841522118852DATUM+ AMS SEVO 8% TEC QUIK-FIL
10841522118845DATUM+ ABBOTT ITALY SEVO 8% TEC QUIK-FIL
10841522118838DATUM+ ABBOTT TURKEY SEVO 8% TEC QUIK-FIL
10841522118807DATUM+ ABBOTT S.AMERICA SEVO 8% TEC QUIK-FIL
10841522118784DATUM+ SEVO 8% TEC QUIK-FIL - TAEMA VD318500
10841522118777DATUM+ 8% SEVO SELECTATEC KEYFILLER
10841522118760DATUM+ ABBOTT 8% SEVO SELECTATEC KEYFILLER

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