MedSource, Non-Contact Infrared Thermometer JXB-178

GUDID 00816703029916

Infrared, Non-Contact Thermometer

MEDSOURCE INTERNATIONAL LLC

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• Primary Device ID: 00816703029916
• NIH Device Record Key: 1762a44c-48c3-4cc6-8ccd-0e2510f2c8df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource, Non-Contact Infrared Thermometer
• Version Model Number: MS-131001
• Catalog Number: JXB-178
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816703029909 [Primary]
GS1	00816703029916 [Package]; Contains: 00816703029909; 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: 2020-12-16
• Device Publish Date: 2020-12-08

Devices Manufactured by MEDSOURCE INTERNATIONAL LLC

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• 00840155406179 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 16Gx1.25
• 00840155413870 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 20Gx1.25
• 00840155413900 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 22Gx1
• 00840155413931 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 24Gx0.75
• 00840155413962 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 20Gx1
• 00840155413993 - MedSource Winged Catheters: 2023-10-16 ClearSafe Comfort I.V. Catheter, 14g x1.25 pur, winged
• 00840155414020 - MedSource Winged Catheters: 2023-10-16 ClearSafe Comfort I.V. Catheter, 16g x1.25 pur, winged