Digital Telemetry 012-0284-11

GUDID 10841522100680

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

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiographic lead set, reusable

• 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

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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

• 10841522129599 - Spacelabs: 2025-03-21 CUFF,ABP,ADULT M,24-32CM/9-13IN,NO LTX
• 10841522130816 - Trulink: 2025-03-21 NIBP,HOSE ASSY,ADULT,12 FT,QUICK RELEASE
• 10841522131431 - OnTrak: 2025-03-07 ABP ONTRAK MONITOR, BRAZIL, 90227
• 10841522100406 - Spacelabs Healthcare: 2025-02-28 ABSORBER, NO BYPASS, 2KG (RE-ROUTE)
• 10841522100413 - Spacelabs Healthcare: 2025-02-28 ABSORBER, NO BYPASS, 1KG (RE-ROUTE)
• 10841522100383 - Spacelabs Healthcare: 2025-02-11 ABSORBER, BYPASS, 2KG (RE-ROUTE)
• 10841522100390 - Spacelabs Healthcare: 2025-02-11 ABSORBER, BYPASS, 1KG (RE-ROUTE)
• 10841522100420 - Spacelabs Healthcare: 2025-02-11 ABSORBER, BYPASS, 2KG (RE-ROUTE) MRI