Infrared Thermometer

GUDID 06948423808817

Shenzhen Pango Electronic Co., Ltd.

Infrared patient thermometer, ear/skin

• Primary Device ID: 06948423808817
• NIH Device Record Key: 9777b934-d0a1-404f-bad2-a9cf5b5e95cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infrared Thermometer
• Version Model Number: PG-IRT1601
• Company DUNS: 529222127
• Company Name: Shenzhen Pango Electronic 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948423808817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182597

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: 2020-04-27
• Device Publish Date: 2020-04-17

On-Brand Devices [Infrared Thermometer]

• 06948423808824: PG-IRT1602
• 06948423808817: PG-IRT1601
• 06948423808763: PG-IRT1603