Stabil-O-Graph

GUDID 04041346020006

IEM GmbH

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 04041346020006
• NIH Device Record Key: 0605abc1-f061-42b1-930b-c5ca37aaba8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stabil-O-Graph
• Version Model Number: mobil
• Company DUNS: 344030150
• Company Name: IEM GmbH
• 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: false
• 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: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de
• Phone: +4924141259300
• Email: customer.relations@iem.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04041346020006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041313

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: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-11-24

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