AriaTele 96281

GUDID 10841522100352

ARIATELE TELEMETRY TRANSMITTER

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter

• Primary Device ID: 10841522100352
• NIH Device Record Key: 43ec1109-084d-463a-b7f9-1582fa577ea1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AriaTele
• Version Model Number: 96281
• Catalog Number: 96281
• 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 -40 Degrees Celsius and 75 Degrees Celsius
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522100352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121480

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: 10
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-10-04

On-Brand Devices [AriaTele]

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