XHIBIT 91393
GUDID 10841522131035
AGILE UPGRADE TEST FOR 9.3.6
SPACELABS HEALTHCARE (WASHINGTON), INC
General-purpose multi-parameter bedside monitor| Primary Device ID | 10841522131035 |
| NIH Device Record Key | 9bd8b78c-b99f-4643-a980-95ca0b5cf1d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XHIBIT |
| Version Model Number | 91393 |
| Catalog Number | 91393 |
| 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 | true |
| Manufacturing Date | false |
| 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 Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 76 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 10 millibar and 50 millibar |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841522131035 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K112962
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 | 2023-05-24 |
| Device Publish Date | 2023-05-16 |
On-Brand Devices [XHIBIT]
| 10841522100345 | XHIBIT CENTRAL STATION,96102 |
| 10841522127069 | XHIBIT CENTRAL STATION,96102 |
| 10841522100536 | DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE |
| 10841522122996 | 96501,XHIBIT XC4 |
| 10841522107832 | CENTRAL STATION,96102,LOANER |
| 10841522107160 | Central Station |
| 10841522131035 | AGILE UPGRADE TEST FOR 9.3.6 |
| 10841522129780 | DISPLAY,21.5",CAPACITIVE TOUCH,BLACK, ANTI-GLARE |
| 10841522117688 | CENTRAL STATION,96102,REFURBISHED |
| 10841522131141 | DISPLAY,21.5",CAPACITIVE TOUCH,BLACK,ANTI-GLARE |
Trademark Results [XHIBIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XHIBIT 85750471 not registered Dead/Abandoned |
XHIBIT, LLC 2012-10-10 |
 XHIBIT 85608415 4818201 Live/Registered |
SPACELABS HOLDINGS, INC. 2012-04-25 |
 XHIBIT 76419802 2872276 Live/Registered |
ActivX Biosciences, Inc. 2002-06-12 |
 XHIBIT 73305310 not registered Dead/Abandoned |
INTERACTIVE DATA CORPORATION 1981-04-10 |
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