Self-Taking Blood Pressure Kit HEM-18

GUDID 00073796000189

Blood Pressure Kit Self-Taking

Omron Healthcare, Inc.

Aneroid manual sphygmomanometer

• Primary Device ID: 00073796000189
• NIH Device Record Key: c50b0085-cb5d-42f3-8436-c09a07aa1693
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Self-Taking Blood Pressure Kit
• Version Model Number: HEM-18
• Catalog Number: HEM-18
• 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: true
• 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	00073796000189 [Primary]
GS1	10073796000186 [Package]; Package: Inner Carton [12 Units]; In Commercial Distribution
GS1	20073796000183 [Package]; Contains: 10073796000186; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780715

FDA Product Code

• 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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