OnTrak 015-0118-04Q

GUDID 10841522102257

CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX,QK DISC/LUER

SPACELABS HEALTHCARE (WASHINGTON), INC

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• Primary Device ID: 10841522102257
• NIH Device Record Key: adcc1e38-0a6a-4460-812d-364670b204cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnTrak
• Version Model Number: 90227
• Catalog Number: 015-0118-04Q
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522102257 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-11-21

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