MedSource Infrared, Non-Contact Thermometer Not Applicable

GUDID 00816703024751

Infrared, Non-Contact Thermometer

MEDSOURCE INTERNATIONAL LLC

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• Primary Device ID: 00816703024751
• NIH Device Record Key: 041d8728-2184-4f42-8d49-10062d04a60c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Infrared, Non-Contact Thermometer
• Version Model Number: MS-131000-RCS
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816703024744 [Primary]
GS1	00816703024751 [Package]; Contains: 00816703024744; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090361

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2021-05-10
• Device Publish Date: 2021-04-30

On-Brand Devices [MedSource Infrared, Non-Contact Thermometer]

• 00816703021354: Infrared, Non-Contact Thermometer
• 00816703024751: Infrared, Non-Contact Thermometer