Welch Allyn

GUDID 04041346101163

IEM GmbH

Blood pressure ambulatory recorder

• Primary Device ID: 04041346101163
• NIH Device Record Key: c57ff7c4-8240-48e1-8429-ab743696c6e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Welch Allyn
• Version Model Number: REUSE-11L-ABPM
• 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	04041346101163 [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 [Welch Allyn]

• 04041346030517: ABPM 7100 Set
• 04041346030500: ABPM 7100
• 04041346032405: HMS WA CD 5.0 CBP
• 04041346101255: REUSE-US-ABPM
• 04041346101194: REUSE-ALL-ABPM
• 04041346101187: REUSE-CSL-ABPM
• 04041346101170: REUSE-12-ABPM
• 04041346101163: REUSE-11L-ABPM
• 04041346101156: REUSE-11-ABPM
• 04041346101149: REUSE-10-ABPM
• 04041346101132: REUSE-09-ABPM
• 04041346030913: ABPM 7100 UPGRADE KIT CBP
• 04041346101477: ABPM 7100 HMS
• 04041346101439: ABPM 7100 Set CBP
• 04041346101415: ABPM 7100 Set
• 04041346101392: ABPM 7100
• 04041346101354: WA HMS 5.0 CBP