Welch Allyn, Inc. REUSE-091012-ABPM

GUDID 04041346031064

ABPM 7100 Small Cuff Set (09, 10 and 12 sizes)

WELCH ALLYN, INC.

Blood pressure cuff, reusable

• Primary Device ID: 04041346031064
• NIH Device Record Key: 1d7a22be-f6fa-45da-a7ad-88f8f871dedb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Welch Allyn, Inc.
• Version Model Number: 901043
• Catalog Number: REUSE-091012-ABPM
• Company DUNS: 198227881
• Company Name: WELCH ALLYN, INC.
• 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

Customer Support Contacts

• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04041346031064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153557

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive
• DXQ: blood pressure cuff

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-25
• Device Publish Date: 2016-09-17

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