XPREZZON L-91393
GUDID 10841522100109
91393 STATIONARY MONITOR, LOANER
SPACELABS HEALTHCARE (WASHINGTON), INC
Single-patient intensive/general healthcare physiologic monitoring system| Primary Device ID | 10841522100109 |
| NIH Device Record Key | eab74f27-7ac2-4990-97ac-fbeef33d037d |
| Commercial Distribution Discontinuation | 2017-03-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | XPREZZON |
| Version Model Number | 91393 |
| Catalog Number | L-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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 75 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841522100109 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2017-03-10 |
On-Brand Devices [XPREZZON]
| 10841522100093 | STATIONARY MONITOR, 91393, REFURBISHED |
| 10841522100109 | 91393 STATIONARY MONITOR, LOANER |
| 10841522100079 | Bedside Monitor |
| 10841522129179 | KIT, MODULE RECORDER, 91393 |
| 10841522131479 | XPREZZON MONITOR,91393 |
Trademark Results [XPREZZON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XPREZZON 85244130 4347173 Live/Registered |
SPACELABS HOLDINGS, INC. 2011-02-16 |
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