Tel-O-Graph

GUDID 04041346102160

LTE 4G capable

IEM GmbH

Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer Telemetric sphygmomanometer

• Primary Device ID: 04041346102160
• NIH Device Record Key: 65b6c63d-d50d-45a0-8ef3-2e9303bb1616
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tel-O-Graph
• Version Model Number: GSM plus
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04041346102160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173895

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: 2
• Public Version Date: 2023-08-30
• Device Publish Date: 2023-01-10

On-Brand Devices [Tel-O-Graph]

• 04041346101279: BT plus
• 04041346101262: GSM plus
• 04041346102160: LTE 4G capable