Tel-O-Graph

GUDID 04041346101262

IEM GmbH

Telemetric sphygmomanometer

• Primary Device ID: 04041346101262
• NIH Device Record Key: bc2bc7d2-5502-447b-adb9-0b8cd8834c11
• 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	04041346101262 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-28
• Device Publish Date: 2022-01-20

On-Brand Devices [Tel-O-Graph]

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