Infrared Thermometer

GUDID 10840061482806

Model: PC828; Brand: None.

Shenzhen Pacom Medical Instruments Co., Ltd.

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin

• Primary Device ID: 10840061482806
• NIH Device Record Key: 815cf375-05ec-4343-8afd-02725e4ec364
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infrared Thermometer
• Version Model Number: PC828
• Company DUNS: 421356348
• Company Name: Shenzhen Pacom Medical Instruments 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	00840061482809 [Primary]
GS1	10840061482806 [Package]; Contains: 00840061482809; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172889

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: 2020-04-23
• Device Publish Date: 2020-04-15

On-Brand Devices [Infrared Thermometer]

• 10840061486804: Model: PC868; Brand: None.
• 10840061482806: Model: PC828; Brand: None.
• 00840061480904: Model: PC809; Brand: None.
• 10840061482905: Model: PC829; Brand: None.
• 10840061481601: Model: PC816; Brand: None.