ABP 90227-1

GUDID 10841522123177

ABP ONTRAK MONITOR, MULTI-LINGUAL

SPACELABS HEALTHCARE (WASHINGTON), INC

Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder

• Primary Device ID: 10841522123177
• NIH Device Record Key: 1a80db07-bb3b-4503-86cf-033e4c60e055
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABP
• Version Model Number: 90227
• Catalog Number: 90227-1
• 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

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 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
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522123177 [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: 9
• Public Version Date: 2020-05-08
• Device Publish Date: 2017-09-15

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• 10841522105067: ABP ULTRALITE MONITOR,MULTI-LINGUAL
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• 10841522124570: UNIVERSAL CUFF COVER STANDARD SIZE - BOX OF 50
• 10841522108341: 90217/90217A Ultralite ABP Monitor, Ambulatory Blood Pressure
• 10841522107719: LOANER - ABP ONTRAK MONITOR, MULTI-LINGUAL
• 10841522105074: Ambulatory Blood Pressure Monitor