COMFORT TOUCH

GUDID 00850024759398

COMFORT TOUCH BLOOD PRESSURE CUFF - MEDIUM

Slv Pharmaceuticals LLC

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• Primary Device ID: 00850024759398
• NIH Device Record Key: 33ccf19b-48db-4e8b-8a72-22bdd2e2ee7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMFORT TOUCH
• Version Model Number: Blood Cuff
• Company DUNS: 081225162
• Company Name: Slv Pharmaceuticals LLC
• 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: false
• 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	00850024759398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160019

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-18
• Device Publish Date: 2021-05-10

On-Brand Devices [COMFORT TOUCH ]

• 00850024759176: Comfort Touch 70% Isopropyl Alcohol Prep Pads (Pack of 100)
• 00850024759169: Comfort Touch Lancets 31G
• 00850024759404: COMFORT TOUCH BLOOD PRESSURE CUFF - LARGE
• 00850024759398: COMFORT TOUCH BLOOD PRESSURE CUFF - MEDIUM