SCHILLER 3.930300

GUDID 07613365000122

The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, percentage of oxygen saturationin arterial blood (SpO2) and pulse rate in adult or adolescent patients during stress tests. The BP-200 plus can be used for patients of both sexes and all races.

Schiller AG

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 07613365000122
• NIH Device Record Key: 6192698d-d8d6-4a91-9947-f500fa967f2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCHILLER
• Version Model Number: BP-200 plus
• Catalog Number: 3.930300
• Company DUNS: 480868538
• Company Name: Schiller AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 572 KiloPascal and 1050 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613365000122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063814

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: 2023-03-09
• Device Publish Date: 2023-03-01

On-Brand Devices [SCHILLER]

• 07613365000139: The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is i
• 07613365000122: The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is i