Xprezzon 040-1765-00

GUDID 10841522129179

KIT, MODULE RECORDER, 91393

SPACELABS HEALTHCARE (WASHINGTON), INC

General-purpose multi-parameter bedside monitor
Primary Device ID10841522129179
NIH Device Record Keyef1a77f1-d3c5-4110-a88f-ac1655cec16a
Commercial Distribution StatusIn Commercial Distribution
Brand NameXprezzon
Version Model NumberXprezzon Monitor
Catalog Number040-1765-00
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522129179 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-17
Device Publish Date2024-06-07

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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