Medium Cuff, Bladder for HEM-907 HEM-907-CR19

GUDID 00073796907020

Blood Pressure Cuff and Bladder for HEM-907 (Medium)

Omron Healthcare, Inc.

Blood pressure cuff, reusable

• Primary Device ID: 00073796907020
• NIH Device Record Key: e2892607-e3fe-4146-b0a2-1b1c948f31b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medium Cuff, Bladder for HEM-907
• Version Model Number: HEM-907-CR19
• Catalog Number: HEM-907-CR19
• Company DUNS: 054318779
• Company Name: Omron Healthcare, 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-634-4350
• Email: ohiquality@omron.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796907020 [Primary]
GS1	10073796907027 [Package]; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032305

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-16

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