OctiveTech

GUDID 00897429002056

Clinical Guard

Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear

• Primary Device ID: 00897429002056
• NIH Device Record Key: 6776c449-e72d-4748-bb76-6db84c2bc235
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OctiveTech
• Version Model Number: FDIR-V1
• Company DUNS: 827033924
• Company Name: Clinical Guard
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00897429002056 [Primary]
GS1	10897429002053 [Package]; Package: Case [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052849

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: 4
• Public Version Date: 2020-12-04
• Device Publish Date: 2016-10-04

Devices Manufactured by Clinical Guard

• 00897429002513 - Clinical Guard: 2022-11-28
• 10897429002701 - Clinical Guard: 2022-06-10
• 00897429002766 - Clinical Guard: 2022-06-10
• 10897429002237 - Clinical Guard: 2021-11-10
• 20897429002463 - Clinical Guard: 2021-11-10
• 00897429002476 - Clinical Guard: 2021-11-10
• 20897429002524 - Clinical Guard: 2021-11-10
• 10897429002978 - Clinical Guard: 2021-11-10