PREX

GUDID 26955647600053

FUDAKANG INDUSTRIAL CO., LTD.

General-purpose patient temperature probe, single-use

• Primary Device ID: 26955647600053
• NIH Device Record Key: 45e4def7-d680-415f-964e-18ec21ea0152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREX
• Version Model Number: BT-A31-BT
• Company DUNS: 544522665
• Company Name: FUDAKANG INDUSTRIAL CO., LTD.
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16955647600049 [Primary]
GS1	26955647600053 [Package]; Contains: 16955647600049; Package: Case [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101387

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: 2020-10-07
• Device Publish Date: 2020-09-29

Devices Manufactured by FUDAKANG INDUSTRIAL CO., LTD.

• 16955647600070 - AUPO: 2020-12-01 Infrared Thermometer
• 16955647600087 - AUPO: 2020-12-01 Blood Pressure Monitor
• 16955647600063 - FDK: 2020-10-28
• 26955647600053 - PREX: 2020-10-07
• 26955647600053 - PREX: 2020-10-07
• 06955647600011 - FDK: 2020-09-23