ABPM cuff

GUDID 04041346101057

IEM GmbH

Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder

• Primary Device ID: 04041346101057
• NIH Device Record Key: 1e9e1dd1-81a2-41b6-9771-c1794788a3e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABPM cuff
• Version Model Number: size L
• 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	04041346101057 [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