SCHILLER

Basic Information

• Brand Name: SCHILLER
• Primary DI: 07613365000122
• Version / Model: BP-200 plus
• Catalog Number: 3.930300
• Company Name: Schiller AG
• Labeler DUNS: 480868538
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-01
• Public Version: 2
• Public Version Date: 2025-02-21
• Public Version Status: Update
• Public Device Record Key: 6192698d-d8d6-4a91-9947-f500fa967f2d

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16173	Automatic-inflation electronic sphygmomanometer, non-portable	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613365000122	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K063814	000

Storage Conditions

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