Spacelabs Healthcare 040-1409-02
GUDID 10841522127021
KIT,SINGLE BAND ACT ANT,W/OPS,PLEN ADC
SPACELABS HEALTHCARE (WASHINGTON), INC
Electrocardiography monitoring system receiver| Primary Device ID | 10841522127021 |
| NIH Device Record Key | 0e615ba1-ffa0-49c2-9684-efbb3e0d3171 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spacelabs Healthcare |
| Version Model Number | 96280 |
| Catalog Number | 040-1409-02 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841522127021 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141156
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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2019-02-25 |
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 |
Trademark Results [Spacelabs Healthcare]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPACELABS HEALTHCARE 86377687 4903660 Live/Registered |
Spacelabs Holdings, Inc. 2014-08-26 |
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