qube R-91390
GUDID 10841522100574
COMPACT MONITOR, 91390, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
Multiple vital physiological parameter monitoring system, clinical| Primary Device ID | 10841522100574 |
| NIH Device Record Key | cc6d7fdf-247d-45ed-8520-ed640a27270f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | qube |
| Version Model Number | 91390 |
| Catalog Number | R-91390 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841522100574 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2021-07-22 |
| Device Publish Date | 2016-11-22 |
On-Brand Devices [qube]
| 10841522100550 | COMPACT MONITOR,91390 |
| 10841522102554 | DOCKING STATION,91390 |
| 10841522100574 | COMPACT MONITOR, 91390, REFURBISHED |
Trademark Results [qube]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUBE 98610950 not registered Live/Pending |
Central Bag & Burlap Co. 2024-06-20 |
 QUBE 98498242 not registered Live/Pending |
Sound Sleep Products Inc. 2024-04-12 |
 QUBE 97612690 not registered Live/Pending |
Quantitative BioSciences, Inc. 2022-09-29 |
 QUBE 97548454 not registered Live/Pending |
Triotech Amusement Inc. 2022-08-15 |
 QUBE 97547902 not registered Live/Pending |
Vlamis, George T 2022-08-14 |
 QUBE 97104646 not registered Live/Pending |
Norix Group, Inc 2021-11-02 |
 QUBE 90975278 not registered Live/Pending |
Queen Bee Distilling LLC 2020-12-02 |
 QUBE 90354220 not registered Live/Pending |
Queen Bee Distilling LLC 2020-12-02 |
 QUBE 88858741 not registered Live/Pending |
QUEVENTIVE, LLC 2020-04-03 |
 QUBE 88753502 not registered Live/Pending |
Seeq Corporation 2020-01-09 |
 QUBE 88753501 not registered Live/Pending |
Seeq Corporation 2020-01-09 |
 QUBE 88709656 not registered Live/Pending |
Aion LED, Inc. 2019-11-27 |
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