SBPM cuff

GUDID 04041346101200

IEM GmbH

Telemetric sphygmomanometer

• Primary Device ID: 04041346101200
• NIH Device Record Key: 801ea73e-ed93-4a24-8eab-05743669aaa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SBPM cuff
• Version Model Number: size S
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	04041346101200 [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 [SBPM cuff]

• 04041346101231: size XL
• 04041346101224: size L
• 04041346101217: size M
• 04041346101200: size S