RENPHO Pulse Oximeter

GUDID 50860002249655

JOICOM CORPORATION

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• Primary Device ID: 50860002249655
• NIH Device Record Key: faa79af9-a6a9-4923-bb80-925298d9f892
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENPHO Pulse Oximeter
• Version Model Number: R-J002
• Company DUNS: 081060692
• Company Name: JOICOM 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002249650 [Primary]
GS1	50860002249655 [Package]; Contains: 00860002249650; Package: Carton [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173123

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-10
• Device Publish Date: 2020-05-24

On-Brand Devices [RENPHO Pulse Oximeter]

• 00860002249636: RP-PO001
• 30850023727009: RP-PO001
• 50860002249655: R-J002