Areta Ketone Urinalysis Reagent Strips (100 tests kit）

GUDID 00850253007000

EASY HEALTHCARE CORPORATION

Urine ketone IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 00850253007000
• NIH Device Record Key: 8591f956-e474-432f-8479-627ee5e38c9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Areta Ketone Urinalysis Reagent Strips (100 tests kit）
• Version Model Number: U031-013
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850253007000 [Primary]
GS1	00850253007017 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	10850253007014 [Package]; Contains: 00850253007017; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061559

FDA Product Code

• CDM: Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-08-01

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