OctiveTech

GUDID 00897429002056

Clinical Guard

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