Blood Pressure Multi-3 Cuff Kit

GUDID 00616784709710

DYNAREX CORPORATION

Aneroid manual sphygmomanometer

• Primary Device ID: 00616784709710
• NIH Device Record Key: b620918d-671d-402f-9669-e721ff0980c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Pressure Multi-3 Cuff Kit
• Version Model Number: 7097
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784709710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043286

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: 2017-11-21

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