Digital Telemetry 012-0284-11

GUDID 10841522100680

LDWR SET,PINCH,DIN,61CM/ 24 IN,AAMI,3LW/ST, 1/ST

SPACELABS HEALTHCARE (WASHINGTON), INC

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• Primary Device ID: 10841522100680
• NIH Device Record Key: 9354824a-7f75-4d22-9e69-a747d495a5e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Telemetry
• Version Model Number: 90347
• Catalog Number: 012-0284-11
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522100680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983996

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: 7
• Public Version Date: 2020-03-17
• Device Publish Date: 2017-03-07

Devices Manufactured by SPACELABS HEALTHCARE (WASHINGTON), INC

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• 10841522118234 - Spacelabs Healthcare: 2024-05-08 DATUM+ 5% HAL SELECTATECSTANDARD FILL DATUM LAB.
• 10841522123184 - Sentinel: 2024-05-08 SENTINEL 10 TEST SYSTEM, STAND ALONE (ENG)
• 10841522123191 - SENTINEL: 2024-05-08 SENTINEL 10 TEST SYSTEM, NETWORKED (ENG)
• 10841522123207 - SENTINEL: 2024-05-08 SENTINEL 10 TEST SYSTEM, RDT
• 10841522125713 - PathfinderSL: 2024-05-08 SENTINEL 10 / PATHFINDER SL KIT NL
• 30841522125557 - EVO: 2024-04-30 KIT,HOOK-UP,ARIA,C/W POUCH