Blood Pressure Kit

GUDID 00616784710037

DYNAREX CORPORATION

Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer

• Primary Device ID: 00616784710037
• NIH Device Record Key: 0e3a0ba2-61a8-4de3-9bc8-40432899f4f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Pressure Kit
• Version Model Number: 7100
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784710020 [Primary]
GS1	00616784710037 [Package]; Contains: 00616784710020; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092245

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: 2016-09-24

On-Brand Devices [Blood Pressure Kit]

• 00616784710037: 7100
• 00616784709932: 7099