HU810-91

GUDID 06945664820677

Reusable SpO2 Sensor/Philips/Y style multi function/all patient/3.0M/087/HENLEYS

Unimed Medical Supplies, Inc.

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• Primary Device ID: 06945664820677
• NIH Device Record Key: bbcaeebb-3eee-45f8-b1a1-749fcdbf8f1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HU810-91
• Version Model Number: HU810-91
• Company DUNS: 527971025
• Company Name: Unimed Medical Supplies, Inc.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945664820677 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142832

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-23

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