ScottCare M25108200

GUDID 04041346100098

IEM GmbH

Blood pressure ambulatory recorder

• Primary Device ID: 04041346100098
• NIH Device Record Key: 31a456c7-cd4d-429d-9ba2-f2dc72ca3b27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScottCare
• Version Model Number: ABP 320
• Catalog Number: M25108200
• Company DUNS: 344030150
• Company Name: IEM GmbH
• 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: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de
• Phone: +49240295000
• Email: service@iem.de

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04041346100098 [Primary]

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: 2016-10-28

Devices Manufactured by IEM GmbH

• 04041346102207 - IEM GmbH: 2023-11-08 Hypertension Management Software Version 6
• 04041346102153 - IEM GmbH: 2023-08-30 Hypertension Management Software Version 6
• 04041346102160 - Tel-O-Graph: 2023-08-30 LTE 4G capable
• 04041346102269 - Mobil-O-Graph: 2023-07-10
• 04041346101354 - Welch Allyn: 2022-06-09
• 04041346101392 - Welch Allyn: 2022-06-09
• 04041346101415 - Welch Allyn: 2022-06-09
• 04041346101439 - Welch Allyn: 2022-06-09