AriaTele L-96281-A09JN

GUDID 10841522107863

OPTION A,ECG TRANSMITTER, W/O DISPLAY, LOANER

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiography telemetric monitoring system transmitter

• Primary Device ID: 10841522107863
• NIH Device Record Key: e927b112-94ba-4b57-b4f4-5c76201019c5
• Commercial Distribution Discontinuation: 2017-03-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AriaTele
• Version Model Number: 96281
• Catalog Number: L-96281-A09JN
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522107863 [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: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-03-10

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