Easy@Home Ketone Test Strips (20 Pack) EZR-101-20(P)

GUDID 00810038631431

Easy@Home Ketone Test Strips (20 Pack)

EASY HEALTHCARE CORPORATION

Urine ketone IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 00810038631431
• NIH Device Record Key: bb058838-5420-47b9-b8d0-2dd96312c1e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Ketone Test Strips (20 Pack)
• Version Model Number: EZR-101
• Catalog Number: EZR-101-20(P)
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038631431 [Primary]
GS1	30810038631432 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170587

FDA Product Code

• JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-25
• Device Publish Date: 2022-02-17

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