ABPM cuff

GUDID 04041346101040

IEM GmbH

Blood pressure ambulatory recorder

• Primary Device ID: 04041346101040
• NIH Device Record Key: 3cfadbbf-bcab-491b-95c9-f59313a44c6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABPM cuff
• Version Model Number: size M
• 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	04041346101040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153557

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 [ABPM cuff]

• 04041346101064: size XL
• 04041346101057: size L
• 04041346101040: size M
• 04041346101033: size S
• 04041346101026: size XS