GUDID 06944413805767

Edan Instruments, Inc.

General-purpose patient temperature probe, reusable

• Primary Device ID: 06944413805767
• NIH Device Record Key: 503a8c17-1bf2-4dfb-a26b-57aee54cd894
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: FT10
• Company DUNS: 529173163
• Company Name: Edan Instruments, 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: 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	06944413805767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131818

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2016-09-01

Devices Manufactured by Edan Instruments, Inc.

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• 06944413839434 - RespArray NIBP cuff: 2024-04-29
• 06944413839441 - RespArray NIBP cuff: 2024-04-29
• 06944413839458 - RespArray NIBP cuff: 2024-04-29
• 06944413839465 - RespArray NIBP cuff: 2024-04-29
• 06944413839472 - RespArray NIBP cuff: 2024-04-29
• 06944413839489 - RespArray NIBP cuff: 2024-04-29
• 06944413839496 - RespArray NIBP cuff: 2024-04-29