XPREZZON N/A

GUDID 10841522100093

STATIONARY MONITOR, 91393, REFURBISHED

SPACELABS HEALTHCARE (WASHINGTON), INC

Single-patient intensive/general healthcare physiologic monitoring system
Primary Device ID10841522100093
NIH Device Record Keyc8bedf2a-0d09-4cb3-8e46-da23b37dce6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameXPREZZON
Version Model Number91393
Catalog NumberN/A
Company DUNS145581588
Company NameSPACELABS HEALTHCARE (WASHINGTON), INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

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Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
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Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
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Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
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Device Identifiers

Device Issuing AgencyDevice ID
GS110841522100093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-02-06
Device Publish Date2016-10-07

On-Brand Devices [XPREZZON]

10841522100093STATIONARY MONITOR, 91393, REFURBISHED
1084152210010991393 STATIONARY MONITOR, LOANER
10841522100079Bedside Monitor
10841522129179KIT, MODULE RECORDER, 91393

Trademark Results [XPREZZON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XPREZZON
XPREZZON
85244130 4347173 Live/Registered
SPACELABS HOLDINGS, INC.
2011-02-16

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