ABP N/A

GUDID 10841522105074

Ambulatory Blood Pressure Monitor

SPACELABS HEALTHCARE (WASHINGTON), INC

Blood pressure ambulatory recorder

• Primary Device ID: 10841522105074
• NIH Device Record Key: c98e78a1-17ad-48c2-9d47-364b81f46798
• Commercial Distribution Discontinuation: 2017-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ABP
• Version Model Number: 90217
• Catalog Number: N/A
• 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: 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 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	10841522105074 [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: 2019-11-08
• Device Publish Date: 2016-12-13

On-Brand Devices [ABP]

• 10841522123177: ABP ONTRAK MONITOR, MULTI-LINGUAL
• 10841522105067: ABP ULTRALITE MONITOR,MULTI-LINGUAL
• 10841522124587: UNIVERSAL CUFF COVER LARGE SIZE - BOX OF 50
• 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