AriaTele 96281

GUDID 10841522100352

ARIATELE TELEMETRY TRANSMITTER

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiography telemetric monitoring system transmitter
Primary Device ID10841522100352
NIH Device Record Key43ec1109-084d-463a-b7f9-1582fa577ea1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAriaTele
Version Model Number96281
Catalog Number96281
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

Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522100352 [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 Number10
Public Version Date2019-12-23
Device Publish Date2016-10-04

On-Brand Devices [AriaTele]

10841522100352ARIATELE TELEMETRY TRANSMITTER
10841522107917OPTION C, MULTIPARAMETER TRANSMITTER, LOANER
10841522107900OPTION C, MULTIPARAMETER TRANSMITTER, LOANER
10841522107894OPTION A,ECG TRANSMITTER, WITH DISPLAY, LOANER
10841522107887OPTION B, ECG TRANSMITTER, DISPLAY, LOANER
10841522107870OPTION B ECG TRANSMITTER, WITH DISPLAY, LOANER
10841522107863OPTION A,ECG TRANSMITTER, W/O DISPLAY, LOANER
10841522107856OPTION A, ECG TRANSMITTER, W/O DISPLAY, LOANER
10841522107849OPTION A, ECG TRANSMITTER, W/O DISPLAY, LOANER

Trademark Results [AriaTele]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARIATELE
ARIATELE
85627178 4397253 Live/Registered
SPACELABS HOLDINGS, INC.
2012-05-16

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