OnTrak 90227-8

GUDID 10841522131431

ABP ONTRAK MONITOR, BRAZIL, 90227

SPACELABS HEALTHCARE (WASHINGTON), INC

Blood pressure ambulatory recorder

• Primary Device ID: 10841522131431
• NIH Device Record Key: 3f15abd2-c53f-4ce6-9dae-d16169c2cd9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnTrak
• Version Model Number: OnTrak
• Catalog Number: 90227-8
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522131431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141113

FDA Product Code

• DXN: System, measurement, blood-pressure, non-invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-07
• Device Publish Date: 2025-02-27

On-Brand Devices [OnTrak]

• 10841522102547: CUFF,ABP,XLGADLT,38-50CM/15-20IN,NO LTX,QKD/LEUR
• 10841522102530: CUFF,ABP,LG ADLT,32-42CM/13-17IN,NO LTX,QKD/LUER
• 10841522102257: CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX,QK DISC/LUER
• 10841522102240: CUFF,ABP,ADLT,24-32CM/9-13IN,NO LTX,QK DISC/LUER
• 10841522102233: CUFF,ABP,SM ADLT,17-26CM/7-10IN,NO LTX,QKD/LUER
• 10841522129261: CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX
• 10841522129247: CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX
• 10841522131431: ABP ONTRAK MONITOR, BRAZIL, 90227