Spacelabs Healthcare 040-1758-00

GUDID 10841522127328

KIT,UPGR,WIRELESS (OPT P),OLD 670-1712-00,91389

SPACELABS HEALTHCARE (WASHINGTON), INC

Transportable physiologic monitoring system

• Primary Device ID: 10841522127328
• NIH Device Record Key: 32c1d40a-fabb-4578-a45b-a13938efd309
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spacelabs Healthcare
• Version Model Number: 91389
• Catalog Number: 040-1758-00
• Company DUNS: 145581588
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522127328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120616

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-30
• Device Publish Date: 2019-04-22

On-Brand Devices [Spacelabs Healthcare]

• 10841522126246: HOLTER LEADWIRE,EVO/ARIA,WHITE.1PK
• 10841522126239: HOLTER LEADWIRES, EVO/ARIA, BROWN. 10PK
• 10841522126222: HOLTER LEADWIRES, EVO/ARIA, ORANGE. 10PK
• 10841522126215: HOLTER LEADWIRES, EVO/ARIA, RED. 10PK
• 10841522126208: HOLTER LEADWIRES, EVO/ARIA, WHITE. 10PK
• 10841522126192: ELECTRODE SNAP LEAD SET,14" RED /WHT/ORN/BRN
• 10841522126185: ELECTRODE SNAP LEAD SET,40" RED /WHT/ORN/BRN
• 10841522126178: ELECTRODE SNAP LEAD SET,14"ORN/BRN/RED,7" WHT
• 10841522126161: ELECT SNP LD SET,18" WHT/BLK/RED/GRN/ORN/BLU/BRN
• 10841522104534: DISPLAY,19", XPREZZON,94267
• 10841522110795: CABLE,ECG,SHLD,24 INCH,3-LEAD,305CM/10FT,IEC
• 10841522110757: CABLE,ECG,24 INCH 3-LW,305CM/10 FT,AAMI
• 10841522110733: CABLE,ECG,SHLD,24 INCH,5-LEAD,305CM/10FT,IEC
• 10841522110719: CABLE,ECG,24 INCH 5-LW,305CM/10 FT,AAMI
• 30841522123041: KIT,HOOK-UP,CASE OF 20,ARIA
• 30841522122860: HOOK UP KIT WITH SINGLE USE POUCH, CASE OF 20
• 10841522109836: PATIENT FLOW SENSOR - SINGLE UNIT
• 10841522127144: LIFECARD CF DIGITAL HOLTER MON
• 10841522127137: LIFECARD CF, 4 LEAD, HOLTER RECORDER
• 10841522127328: KIT,UPGR,WIRELESS (OPT P),OLD 670-1712-00,91389
• 10841522127311: KIT,UPGRADE,WIRELESS (OPT P) OLD DISPLAY,91390
• 10841522127304: KIT,UPGRADE,WIRELESS (OPTION P),MONITORS
• 10841522108822: CAPNO POD, 92516, REFURBISHED
• 10841522124884: 4 ELECTRODE EVO, BELT MOUNTED, PACKED, FRENCH
• 10841522126864: ABP ONTRAK MONITOR, GERMAN
• 10841522125416: LIFECARD CF DIGITAL HOLTER MON
• 10841522119347: DATUM+ ABBVIE INT SEVO 8% C/M QUIK-FIL - ENGLI
• 10841522119330: DATUM+ ABBVIE QUIL-FIL SEVO 8% C/M SPANISH
• 10841522119316: DATUM+ABBVIE 5% ISO SELECTATEC STANDARD FILL
• 10841522119309: DATUM+ABBVIE 5% ISO CAGEMOUNT STANDARD FILLER
• 10841522119026: DATUM+ ABBOTT INT SEVO 8% N.A.D. QUIK-FIL ENG
• 10841522119019: DATUM+ ABBOTT INT. SEVO 8% NAD QUIK-FIL SPANISH
• 10841522119002: DATUM+ ABBOTT 8% SEVO N.A.D. KEYFILLER
• 10841522118982: DATUM+ ABBVIE SPAIN SEVO 8% DRAGER QUIK-FIL
• 10841522118975: DATUM+ 8% SEVO DRAEGER QUICKFILL - MEDITEC
• 10841522118968: DATUM+ ABBOTT SPAIN SEVO 8% DRAGER QUIK-FIL
• 10841522118944: DATUM+ 8% SEVO DRAEGER QFILL ABBOTT AUSTRALASIA
• 10841522118937: DATUM+ ABBOTT INT.SEVO8% DRAGER QUIK-FIL SPANISH
• 10841522118920: DATUM+ SEVO 8% DRAGER KEYFILLER - DATUM
• 10841522118913: DATUM+ ABBOTT 8% SEVO DRAGER KEYFILLER
• 10841522118906: DATUM+ SEVO 8% DRAGER KEYFILLER - BLEASE
• 10841522118883: DATUM+ SEVO8% SELECTATEC QUIK-FIL - ANMEDIC
• 10841522118876: DATUM+ SEVO 8% TEC QUIK-FIL - MEDITEC
• 10841522118852: DATUM+ AMS SEVO 8% TEC QUIK-FIL
• 10841522118845: DATUM+ ABBOTT ITALY SEVO 8% TEC QUIK-FIL
• 10841522118838: DATUM+ ABBOTT TURKEY SEVO 8% TEC QUIK-FIL
• 10841522118807: DATUM+ ABBOTT S.AMERICA SEVO 8% TEC QUIK-FIL
• 10841522118784: DATUM+ SEVO 8% TEC QUIK-FIL - TAEMA VD318500
• 10841522118777: DATUM+ 8% SEVO SELECTATEC KEYFILLER
• 10841522118760: DATUM+ ABBOTT 8% SEVO SELECTATEC KEYFILLER